U.S. GOVERNMENT PRINTING OFFICE

66–079 CC WASHINGTON : 2000

COMPENSATING VACCINE INJURIES: ARE REFORMS

NEEDED?

HEARING

BEFORE THE

SUBCOMMITTEE ON CRIMINAL JUSTICE,

DRUG POLICY, AND HUMAN RESOURCES

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

FIRST SESSION

SEPTEMBER 28, 1999

Serial No. 106–136

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

HELEN CHENOWETH, Idaho

DAVID VITTER, Louisiana

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

DAVID A. KASS, Deputy Counsel and Parliamentarian

CARLA J. MARTIN, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY, AND HUMAN RESOURCES

JOHN L. MICA, Florida, Chairman

BOB BARR, Georgia

BENJAMIN A. GILMAN, New York

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

ASA HUTCHINSON, Arkansas

DOUG OSE, California

DAVID VITTER, Louisiana

PATSY T. MINK, Hawaii

EDOLPHUS TOWNS, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

JANICE D. SCHAKOWSKY, Illinois

EX OFFICIO

DAN BURTON, Indiana HENRY A. WAXMAN, California

SHARON PINKERTON, Staff Director and Chief Counsel

MASON ALINGER, Professional Staff Member

LISA WANDLER, Clerk

CHERRI BRANSON, Minority Counsel

(III)

C O N T E N T S

Page

Hearing held on September 28, 1999 ..................................................................... 1

Statement of:

Balbier, Thomas E., Jr., Director, National Vaccine Injury Compensation

Program, Department of Health and Human Services; John L. Euler,

Deputy Director, Torts Branch, Civil Division, Department of Justice .... 102

Clements, Michele, petitioner and mother of injured child, Milwaukee,

WI; Linda Mulhauser, petitioner and mother of injured child, New

York, NY; and John Salamone, president, Informed Parents Against

VAPP .............................................................................................................. 17

Kinsbourne, Marcel, medical expert, Tufts University; Arnold Gale, medical expert, Stanford University; and Cliff Shoemaker, attorney, Shoemaker & Horn ............................................................................................... 51

Letters, statements, et cetera, submitted for the record by:

Balbier, Thomas E., Jr., Director, National Vaccine Injury Compensation

Program, Department of Health and Human Services:

Information concerning timelines ............................................................ 195

Prepared statement of ............................................................................... 105

Burton, Hon. Dan, a Representative in Congress from the State of Indiana, information concerning backgrounds............................................... 131, 147

Clements, Michele, petitioner and mother of injured child, Milwaukee,

WI, prepared statement of ........................................................................... 22

Euler, John L., Deputy Director, Torts Branch, Civil Division, Department of Justice, prepared statement of ....................................................... 115

Gale, Arnold, medical expert, Stanford University, prepared statement

of ..................................................................................................................... 65

Kinsbourne, Marcel, medical expert, Tufts University:

Information concerning a final argument by Justice of Department .... 53

Prepared statement of ............................................................................... 58

Mica, Hon. John L., a Representative in Congress from the State of

Florida, prepared statement of .................................................................... 6

Mink, Hon. Patsy T., a Representative in Congress from the State of

Hawaii, prepared statement of .................................................................... 15

Mulhauser, Linda, petitioner and mother of injured child, New York,

NY, prepared statement of ........................................................................... 31

Salamone, John, president, Informed Parents Against VAPP, prepared

statement of ................................................................................................... 37

Shoemaker, Cliff, attorney, Shoemaker & Horn, prepared statement of ..... 75

(1)

COMPENSATING VACCINE INJURIES: ARE

REFORMS NEEDED?

TUESDAY, SEPTEMBER 28, 1999

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY,

AND HUMAN RESOURCES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The subcommittee met, pursuant to notice, at 10 a.m., in room

2154, Rayburn House Office Building, Hon. John L. Mica (chairman of the subcommittee) presiding.

Present: Representatives Mica, Barr, Mink, Cummings, Kucinich,

and Tierney.

Also present: Representatives Burton, Weldon, and Waxman.

Staff present: Sharon Pinkerton, staff director, chief counsel;

Steve Dillingham, special counsel; Mason Alinger, professional staff

member; Lisa Wandler, clerk; Cherri Branson, minority counsel;

Ellen Rayner, minority chief clerk; and Jean Gosa, minority staff

assistant.

Mr. MICA. Good morning. I would like to call this meeting of the

Subcommittee on Criminal Justice, Drug Policy, and Human Resources to order.

This morning’s hearing is entitled, Compensating Vaccine Injuries: Are Reforms Needed? I would like to start with an opening

statement, and then we will yield to other Members for the same

purpose.

Today, our subcommittee will examine a program that is responsible for one of our Government’s most sensitive and difficult responsibilities; the duty to compensate fairly, adequately, and efficiently those individuals who are injured or die as a consequence

of our universal vaccination policy.

This policy is designed to protect us. Without a national vaccine

policy, many illnesses, including measles, polio, diptheria, tetanus,

and typhus, would endanger all of us especially our children. Research into hundreds of new vaccines, which range from lowering

cholesterol to curing AIDS, is proceeding at a rapid pace. Our need

for new vaccines is an absolute certainty.

This subcommittee recently held a hearing on the international

AIDS epidemic and related drug treatments and prevention responses. We learned that vaccine development represents the best

long-term solution for preventing millions of AIDS-related deaths.

I can assure you that people across the globe are anxiously awaiting an effective vaccine for that deadly illness.

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I commend the many researchers and pharmaceutical companies

for vaccine successes to date, and I wish them God speed in developing new, safer, and more effective vaccines for the future. I also

commend those who help to administer vaccines. They have strong

support in Congress for accomplishing these critical missions.

Earlier this year, our subcommittee examined adverse reactions

that have been linked to the hepatitis B vaccine. Last month, our

full committee examined anthrax vaccines and vaccination practices. Today, we will focus on the workings of the HHS Vaccine Injury Compensation Program that was designed to compensate those

individuals who are injured from certain vaccines that we routinely

administer to our children.

Despite the life-saving benefits of our national vaccine practices,

we must not forget the cost of these benefits, particularly to those

individuals and families who regrettably experience tragic adverse

reactions. In simple terms, our vaccines now protect millions. However, in some rare instances they cause serious harm, even death,

to others.

Today, we will examine how we compensate those who are

harmed and consider how we might make the system we have established for this purpose, again, of compensating individuals, work

even better.

The issue of compensating vaccine injuries is not a partisan

issue. In 1984, my brother, Dan Mica, who was a Democrat Member of Congress, helped work with other Members of Congress in

creating an awareness for the need to compensate persons injured

from vaccines. Also a leading figure in helping to create compensation for those who received injury was the ranking member of our

full committee, Mr. Waxman. He was a key author of the vaccine

compensation legislation developed in the eighties.

Our hearing today is devoted to examining the workings of the

National Vaccine Injury Compensation Program administered by

HHS. Is this program, which was established to be a no-fault compensation program, operating in a quick, easy and fair manner, as

was originally envisioned by Congress? Is the fund being administered as required under the law, ‘‘with generosity,’’ in keeping with

the program’s authorization language?

In answering these questions, we will hear first-hand from witnesses who have had experience in the program dealing with injuries particularly to their children. We will also hear from attorneys

who represent the injured and from experts who provide medical

advice at compensation hearings. Finally, we will discuss program

issues with Government witnesses who administer the program.

Recently, we have received many letters, calls, and visits from

families of children injured after they were administered vaccines.

We also have heard from practicing attorneys, medical professionals, and associations with strong interests in this program.

According to many, the current Compensation Program is not operating fairly or in the way Congress originally intended. I want

to learn more about these concerns and some of the problems

brought to our attention from both sides and what should be done

to correct these problems.

Today, we will hear that our national vaccine practices can have

rare but sometimes brutal consequences for those who unfortuVerDate 11-MAY-2000 09:43 Nov 27, 2000 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 C:\DOCS\66079.TXT HGOVREF1 PsN: HGOVREF1
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nately and through no fault of their own, experience severe and

sometimes even deadly adverse reactions. We will also examine the

serious problems experienced by some who have sought compensation, again, under this system that Congress created.

Today, we will hear more about these concerns and recommendations for our Compensation Program. Some issues that I hope will

be addressed today and which may require legislative changes include some of the following: first, is the Compensation Program too

adversarial; are eligibility and standard of proof requirements too

strict; should we use the compensation fund for other purposes?

To address the first question, why must injured families assume

the role of petitioners and often go through a cumbersome adversarial and legal process to get final compensation determination?

Legislative history indicates that Congress intended just the opposite. The process was intended to be informal and take no longer

than 240 days. Many cases now take years; in some cases, as long

as 5, 6, even 9 years to reach a final determination.

Why is this? Why must families hire specialist attorneys to process their claims? Why are attorneys declining in some cases to deal

with these cases? Why are attorney fees not being paid until sometimes years afterwards?

Families of the injured must now search for the few medical experts who are willing to testify on their behalf. Should medical witnesses have their professional credibility challenged by skilled Department of Justice attorneys seeking to protect the Government

coffers? Must some families devote their life savings, incur huge

debt, and experience personal hardship while litigation drags on for

years? These problems may or may not be typical, but they do raise

the issue of whether reforms and safeguards are needed today.

Other questions I hope we address in this hearing: Should the

Department of Justice be reimbursed by injured families for costs

of unsuccessful litigation in the Federal Circuit Court? Should the

Government favor and facilitate mediation in place of litigation? Do

we, in fact, victimize again families that have already suffered terrible harm through what has turned into an adversarial process?

I wish to learn more about this today from the Government, from

the families, from their attorneys, and from the medical experts

who we have assembled as witnesses.

The second concern I would like to address is whether eligibility

and standard of proof requirements are too strict. Program participants have told our subcommittee that the vaccine injury table, the

key to deciding claims, is unnecessarily restrictive. In fact, since

1986, HHS has restricted coverage dramatically through changes to

the injury table. Were the changes always consistent with medical

research, and were they necessary?

I realize that some will argue that the changes reflect sound

science, which we all support. However, that the table was not designed to reflect only studies with conclusive proof of likely injury

cases, conditions, or time requirements. The table also reflects compensation policy. I understand that judges in the Federal Circuit

Court have raised the issue in a pending case as to the constitutionality of giving the HHS Secretary authority to revise the injury

table.

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What will DOJ and HHS do if the court rules against HHS and

the revised table? Will the court stop the program? What would

happen to claims that were denied? I think there are many unanswered questions here, and I hope that we can learn about some

of these problems and solutions from our witnesses.

In summary, I think some very serious programmatic and legal

issues have been raised that need to be resolved. A key issue is the

injury table. Congress designed the original injury table with sort

of a cushion that included injuries where the science was unclear.

Although some research has occurred since then, much uncertainty

remains as to the causes of many childhood illnesses.

Families and others have expressed skepticism about relying on

a rigid chart that has been significantly tightened by HHS. Perhaps the criteria and the spirit of the original table should be preserved. Considering the incompleteness of vaccine injury research,

I can understand their concerns.

Also, the standard of proof requirements may need to be reexamined. For example, a claimant’s burden might be one of simply

demonstrating that the vaccine was related to the injury. The Department of Justice could be required to show by clear and convincing evidence that the injury resulted from something else in order

to defeat the claim.

These are types of simple changes that should be explored to ensure fairness under circumstances where everyone agrees the

science is incomplete and regretfully will remain incomplete for

many years to come. We must all recognize that the standards of

proof that are applied in compensation determinations are legal in

nature and not scientific.

Finally, I realize that the Federal Government has other benefit

programs, such as those for veterans and law enforcement officials,

which provide that the benefit of the doubt goes to the injured in

resolving benefit claims. Why does this program provide no benefit

of the doubt for injured children?

The third aspect I would like to address is whether we should

be using the compensation fund for other purposes. Recent proposals call for using the injury compensation fund for other purposes,

including research and administrative expenses. While hundreds of

potential vaccines are being developed and concerns have been

raised about restrictions in the injury table, it does not seem to me

that it is now the time to reduce the vaccine tax or to raid the trust

fund. The current tax of 75 cents per dose is not exorbitant, and

the cushion in the fund may only be temporary.

Who can accurately predict what new vaccines and groups of injured persons will need to be covered in the future? I urge caution

before using the trust moneys to fund immediate or less compelling

needs. If the fund continues to grow over time, we might consider

changes.

In terms of vaccine tax reduction, I think we should first consider

redirecting or eliminating that portion of the vaccine tax, 25 percent, that goes into the general fund. Then we might consider use

of moneys in the trust fund.

Finally, there is the issue of a possible conflict that exists in having the Compensation Program as part of HHS. HHS conducts and

encourages vaccine research and promotes vaccination policies and

5

programs. Concerns of possible conflicts increase when considering

the Advisory Commission that oversees the Compensation Program. Should the commission use HHS staff? Should HHS override

commission recommendations?

I look forward to hearing from our witnesses today on these and

other issues. I extend my sincere thanks to those who have traveled long distances at great personal sacrifice to be with us and

provide testimony. We sincerely appreciate your willingness to

share your thoughts, your concerns and your recommendations on

these important issues.

[The prepared statement of Hon. John L. Mica follows:]

6

7

8

9

Mr. MICA. Now I am pleased to yield—Mrs. Mink, did you want

me to yield to Mr. Waxman?

Mrs. MINK. Yes.

Mr. MICA. Mr. Waxman, and I know he has another engagement.

Mr. WAXMAN. Thank you very much, Mr. Chairman, and I want

to thank Mrs. Mink for allowing me to go forward first with my

opening statement. Unfortunately, I have a conflict. There is another committee meeting at this very same time, so I am going to

be bouncing back and forth.

But I did want to be here for the beginning of this hearing to express some of my thoughts. And I, first of all, want to thank you,

Mr. Chairman, because it is important for Congress to exercise its

oversight responsibilities by evaluating programs to see what

changes are needed to improve these programs.

I have a special concern about this issue, because I was the author of the Vaccine Compensation Program in 1986. We enacted

this legislation because people were faced with only one alternative

and that was to go into court, a very tough alternative. It was

clearly adversarial to try to establish sufficient evidence in order

to get compensation and then to establish the damages for compensation. It struck us as an inefficient way to compensate people

who deserve to be compensated.

The idea was to have a fair and timely, no-fault alternative to

litigation for individuals who suffer vaccine-related injuries. The

program is charged with using the best available science in developing the table of compensable vaccine injuries, and it was intended to rely on the advice of an Advisory Commission on Childhood Vaccines that was to bring together all the people who have

a stake in the system working effectively.

There were three key reasons for creating the Compensation Program. These reasons are a good measure of whether it is working

as intended. First, we wanted to compensate children who were injured by vaccines, which society felt were essential to public health.

Second, we wanted to give parents confidence that if their child

were to be injured by a vaccine, there would be predictable and

generous compensation. In the absence of such assurance, immunization rates, we felt, were sure to fall. And, finally, we wanted to

prevent manufacturers from abandoning research into safer vaccines, which is what they did in the 1980’s when the number of

such companies dropped from 20 to just 3.

Now, we as a society want immunizations to be available. We

want companies to manufacture these products and to continue to

research how to make these products safer. We thought that with

this vaccine compensation system, we would be providing that incentive.

I know there had been a long-standing debate over the timeliness

of the program and about the scientific proof underlying vaccine injuries listed on the vaccine injury table. We tried to strike an important balance that we thought should have been respected. Victims of vaccine-related injuries are to be compensated. Any lawyer

or plaintiff will tell you that the process is less adversarial than

litigation, and the CDC reports that immunization rates are at a

record high.

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But it is clear this program isn’t working perfectly. Congress has

acted twice to change the program, to make it more no-fault and

less adversarial. The administration recently forwarded recommendations for procedural reforms, which I look forward to moving ahead with legislatively. And today’s hearing will be helpful in

giving us further guidance as to changes that we need to make the

system work as we intended.

There have been disputes about the science and epidemiology of

vaccine injury. We have always erred on the side of compensating

children, if there was a scientific argument that injuries were vaccine related. At least that was always our intent—to err on the side

of making sure that we compensated people who were injured.

We have tried to rely on the best available scientific evidence

when revising the vaccine injury table. Injuries have been added,

and injuries have been removed from that table. But in 13 years,

it has never been Congress’ rule to second-guess the scientists. It

would be a disservice to the public health if we were to start to do

that today.

At every hearing held this year concerning vaccines, I have made

the point of emphasizing the tremendous public health value of immunizations. More Americans have been saved by vaccines than by

any other medical intervention. Across the globe, 21⁄2 million children die every year from childhood diseases. Another 750,000 are

crippled by these diseases. But American children are shielded

from this death and misery by vaccinations.

I mention these terrible statistics because I know no one on this

committee would want to discourage American parents from immunizing their children. But we want to be sure that when there are

rare injuries, we want those children to be compensated. That is

why we enacted the Childhood Vaccination Compensation Program.

It was supposed to be a no-fault, less adversarial, more efficient

way of compensating people so that we wouldn’t push these cases

into the courts.

But we left the door open for people to go to court, because we

didn’t want them to be precluded from the opportunity to present

their case in a court, if the compensation system was not working.

I want us to see whether we have accomplished these goals, do

what we need to change the system so that we make it fair to everybody involved. It is important that the system work. A child

who is hurt should be compensated. The parents of that child who

go into that system shouldn’t be faced with all the barriers that

they have in a court system. I have a strong feeling about this compensation system, and I am hopeful that we can be sure through

our oversight that the program is living up to its objectives.

I am going to be able to review the record. Some of you will notice that very few Members are here, but the record is important,

and will be available for all of our colleagues and everyone else to

evaluate. I will look forward to reviewing the record, if I am not

here to receive the testimony so that the totality of the record will

give us guidance as to how to accomplish our important goals for

this program.

Thank you, Mr. Chairman, for holding the hearing, and I yield

back the balance of my time.

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Mr. MICA. Thank the ranking member of the full committee for

his testimony—actually, for his opening statement, for his leadership on the issue, and authorship of this Compensation Program.

I am now pleased to recognize the chairman of our full Committee on Government Reform, the gentleman from Indiana, Mr. Burton.

Mr. BURTON. Thank you, Mr. Chairman. You can call this my

opening statement and my testimony.

I am pleased that you are holding this hearing today on the Vaccine Injury Compensation Program. As part of our ongoing investigation coming out of both this subcommittee and Mr. Shay’s subcommittee, and the issues the full committee uncovered, there is

much to be concerned about within the Vaccine Program.

No one is suggesting that we do away with vaccines to protect

the public at large. However, we also have a responsibility to protect individuals and their families as well. One way of doing that

will be to conduct good research in looking at ways to minimize adverse events with vaccines and to develop safer vaccines and to inform parents of small children of possible risks due to side effects.

Now, the chairman said there are rare side effects, and I may be

the exception to the rule, but my granddaughter got a hepatitis B

shot and within 6 hours she was in the hospital, about to quit

breathing, she turned blue, and she was dying—within 6 hours.

My grandson, the only other grandchild I have, had five shots in

1 day. He had been perfectly normal up to the time he was receiving these shots, and now he is autistic. Two out of two—rare?

We had a man testify before the full committee from Oklahoma

University who said that 50 percent—he is a scientist, doctor—said

that 50 percent of the kids that got the DPT shot had some side

effects—50 percent. Rare? Were the parents informed about that?

Was my daughter informed about it? For either of her children? Do

children really need the hepatitis B shot between the time they are

born and 5 years old when hepatitis B can only be communicated

through blood, sex, or the mother being infected with it?

Congress as a way of providing compensation—and I want to tell

you, we are going to dig into this—the subcommittee or the full

committee—until heck won’t have it.

I mean, I am telling you, parents and grandparents, and everybody else ought to know the risks of these vaccines. Granted, they

help everybody. They help the society. They have kept our incidence of major epidemics down to almost zero. But parents still

have the right to know the possible side effects of these vaccines,

and it is criminal not to let them know. They should have all the

information. Lincoln said, ‘‘Let the people know the facts, and the

country will be safe.’’ Well, the same thing applies to medicine.

Congress, as a way of providing compensation, enacted the National Vaccine Injury Compensation Program, subtitle 2 of title 21

of the Public Health Service Act, on October 1, 1988. The Compensation Program is administered jointly by the Department of

Health and Human Services, U.S. Court of Federal Claims, and the

Department of Justice. It was designed as a Federal no-fault system designed to compensate those individuals or families of individuals who have been injured by childhood vaccines.

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Now, let me just tell you a little bit about our family, these two

grandchildren of mine. Do you know we can’t find an attorney to

take on this responsibility? This is supposed to be a no-fault system. The chairman of this committee’s grandkids are going to have

to fight in court to get compensation in a no-fault system. Baloney!

And I want to find out if the pharmaceutical companies are behind

any of this.

And unfortunately we are hearing heartwrenching stories, too

many to discount, that indicate that this no-fault system has become emotionally and financially devastating for families. My staff

received a letter just yesterday from a woman whose child died

from the vaccine, and the attorney from the Government grilled her

on everything from how many compressions she gave her daughter

when trying to resuscitate her to what her educational level was.

No fault? Her daughter’s death certificate stated the death was due

to recent DPT and HB vaccines, and she was grilled and grilled

and grilled. Why? No fault?

Why must a parent be subjected to grilling by government lawyers who are oftentimes cruel in their questioning, especially when

the evidence from the experts clearly states the death is related to

a vaccine? This type of behavior from Government lawyers must

stop, and we intend to make sure it does stop, if I have to bring

everybody from HHS, FDA, and everybody else up here every day.

That has to stop, and the people that are in charge of these programs, that has to stop.

If there is a legitimate reason for those people to be compensated, they shouldn’t have to go through this. Losing the child— this woman losing this child is enough pain for her. Or seeing your

child in an incapacitated state, that is enough pain for them. They

don’t need to fight this thing out three or four times in court.

The Department tells us that it typically takes 2 years for a family to go through the Compensation Program. However, we are

hearing from lawyers and families that the process is often much

longer—4 years, 4 years or more for many, and the Department

sometimes even suggests to families that they just give up their

case. No fault? No fault? This type of attitude is deplorable! How

much money is in that program—$1.4 billion, one thousand four

hundred million dollars.

As I stated at our August 3 hearing, the committee will continue

investigating the various facets of the Vaccine Program, including

the Compensation Program until we can be confident that, one,

vaccines are safe and effective; two, that there is adequate research

in the long-term safety and the interaction between vaccines; three,

that all ingredients and fillers in vaccines are safe; four, that families and their attorneys are adequately compensated in a timely

fashion; and, five, that the Government is not keeping families

from being compensated for injuries and death related to vaccines

through administrative changes, through bureaucratic red tape, or

through bullying, and, finally, that families are informed of the

possible side effects and the risks.

And I also want to find out if people at HHS, FDA, or any of the

other Federal health institutes are getting honorariums, free travel, or any other kind of compensation, directly or indirectly, from

pharmaceutical companies that have a vested interest in these

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things being on the market. And to that end, we have already

asked for all the records from the various people in these agencies

to check those out.

Parents should have confidence in their Government and their

health agencies, and they shouldn’t have to fight when their kids

are injured by vaccines.

Thank you, Mr. Chairman.

Mr. MICA. Thank the chairman of our full committee for his

opening statement and also personal testimony.

I would like to recognize now the ranking member of our subcommittee, the gentlelady from Hawaii, Mrs. Mink.

Mrs. MINK. Thank you, Mr. Chairman, and I thank you for holding today’s hearing on the National Vaccine Injury Compensation

Program.

And I concur with the statement just made by the chairman of

the full committee, Mr. Burton. I think that there are some serious

problems in the program and in the way that it is being administered, and I concur that this committee should undertake an extensive examination of the problems.

As the ranking member of this subcommittee, I receive a number

of letters from all across the country suggesting the difficulties that

people are encountering. Notwithstanding the fact that the assumption was that it was to be a no-fault system of compensation,

many of the families affected by the immunization problems have

had enormous difficulty in receiving their due process.

The Congress has attempted to make various amendments to the

law designed to make it less adversarial, but obviously we have not

gone far enough.

Mr. Chairman, in 1991, one of my constituents filed a claim with

the program on behalf of her deceased spouse who had died of polio

shortly after receiving the Salk oral polio vaccine. The courts ruled

against her; she filed an appeal; the court rejected the appeal, because the attorney failed to list objections justifying the appeal.

The court did not allow the attorney to amend the appeal or grant

an extension to conform with this technical objection. The case was

dismissed, and the final irony, Mr. Chairman, is that the petitioner

received no compensation for the death of her husband yet the Government paid her attorneys fees.

Mr. Chairman, when we established this program, we envisioned

a system in which citizens would be able to file claims without assistance from attorneys. It does not appear that this is the system

that we currently have. Virtually all petitioners feel the need to get

legal counsel, because the system is so complicated, and the demand for proof and connection between the injury and the vaccination is so immense that the program has been moved into, again,

a very adversarial one, far greater than what the Congress intended.

There are several reform proposals that I believe we should examine. The statute of limitations, for one. Adding specific injuries

to the table as medical evidence shows that there is a causal link

to the vaccine, and that ought to be extended. Allowing compensation for the cost of setting up a guardianship for an injured child,

and counseling of the families ought to be included as part of the

compensation.

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I would caution against proposals to slash the tax rate on the

vaccines. This is a program that is, I think, well grounded, and the

fact that there is a surplus in the trust fund I do not believe indicates the lack of necessity for the tax that is currently invoked;

rather, it is because of the very stringent, conservative manner in

which these cases are processed that the trust balance has now

grown to over $1 billion.

So, I would hope that the hearings that we shall be conducting

in the subcommittee as well as the full committee will underscore

the importance of this program, the necessity of rendering it into

a true no-fault process, and granting these individuals not only the

notice that the chairman of the full committee insists is appropriate but also the compassion and considerate handling of these

cases once they have come to the Government’s attention.

Thank you, Mr. Chairman.

[The prepared statement of Hon. Patsy T. Mink follows:]

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Mr. MICA. Thank the gentlelady.

Now I’d like to recognize Mr. Barr. Did you have an opening

statement? All right.

And we have also been joined by another of our colleagues, Dr.

Weldon, the gentleman from Florida. Did you have a comment or

opening statement?

Dr. WELDON. Mr. Chairman, I want to thank you for recognizing

me. I believe the people who have preceded me have very eloquently explored all the issues that we are needing to deal with

here.

I just want to thank you for extending an invitation to allow me

to be here as part of this hearing and, as well, the ranking member

for concurring. And I am very pleased to see that a bipartisan consensus is drawing to the same conclusion that I have that we need

to make changes in the Vaccine Injury Compensation Program;

that it is not working the way its authors intended it to work, and,

therefore, your timing on this hearing is very critical.

And I yield back. Thank you.

Mr. MICA. I thank the gentleman, and we will have additional

statements added to the record, without objection.

We will now proceed with our first panel, and I would like to call

forward those witnesses.

The first panel consists of Michele Clements who is a petitioner

and mother of an injured child from Milwaukee, WI. The second

panelist is Linda Mulhauser, and she is also a petitioner and mother of an injured child, and she is from New York City, NY. And our

third panelist is Mr. John Salamone, president of Informed Parents

Against VAPP. We have those three witnesses.

This is an investigations panel and oversight subcommittee of

Congress. We do swear in our witnesses, so if you would remain

standing, raise your right hands.

[Witnesses sworn.]

Mr. MICA. Thank you. Witnesses answered in the affirmative,

and I think these three panelists can give us some insight as to

their personal experience with the compensation fund. I might say

that we try to limit each of our oral witness testimonies to 5 minutes. If you have additional lengthy statements or other documentation you would like to have included as part of the record,

I would be glad to do that by unanimous consent.I21We do have

a request from Michele Clements, our first panelist, for presentation of I think approximately a 1-minute video. Is that correct?

Ms. CLEMENTS. Correct.

Mr. MICA. Without objection, we will also allow introduction of

that video.

I would, with those comments, then, like to recognize Michele

Clements, our first panelist.

STATEMENTS OF MICHELE CLEMENTS, PETITIONER AND

MOTHER OF INJURED CHILD, MILWAUKEE, WI; LINDA

MULHAUSER, PETITIONER AND MOTHER OF INJURED

CHILD, NEW YORK, NY; AND JOHN SALAMONE, PRESIDENT,

INFORMED PARENTS AGAINST VAPP

Ms. CLEMENTS. Thank you, Chairman Mica and——

Mr. MICA. Did you want to show that first?

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Ms. CLEMENTS. Pardon? Yes.

Mr. MICA. OK. Then we will just go ahead and show that video.

[Video.]

Ms. CLEMENTS. I don’t hear the sound to it. Basically, this is the

beginning of Andrew’s day and starting out with his medicines, his

feeds, and things like that. And I think all we are going to see is

the starting of his feeds.

[Video.]

Ms. CLEMENTS. I do this on average maybe—not maybe, but four

times a day, but I also give him medications the same way— through his stomach. So, on average it is about eight times a day

I have to feed him or medicate him through his stomach.

Mr. MICA. If you could proceed with your testimony.

Ms. CLEMENTS. OK, thank you.

Mr. MICA. And you might pull that mic as close as you can so

we can hear you. Thank you.

Ms. CLEMENTS. OK. Once again, I want to thank you, Chairman

Mica and the members of the committee, for allowing me to share

my son’s life and my life as to what happened after he was vaccinated.

The day I found out that I was pregnant was a great joy. We

couldn’t wait for his entry into this world. It took us 3 months to

pick his name, because it was something we wanted him to be

proud of throughout his life. Strong, kingly and manly is the meaning of his name. On January 31, 1992, he entered this world a

healthy, beautiful baby boy. We wanted the best for him as we did

for our other son, Michael.

We don’t allow smoking, drinking or drugs in our home, because

we want a safe and healthy environment for our children. We took

our sons to the doctor for their well care checkups as scheduled and

vaccinated them, because it was the best way to protect them from

life threatening illnesses. We didn’t know about all the adverse reactions that can come with vaccinating our children.

On August 6, 1992, we were thrown into a world that many experience but few know little about: the horror of what the DPT vaccine can do to some children.

My husband, Scott took 7 month old Drew in for his checkup and

the third DPT shot. I asked my husband to make sure the doctor

gave Drew a check-up to see that all was well with him before he

got his shots. I called Scott from work after the doctor’s appointment to find out how Drew was doing. My husband explained that

Drew had been sleeping since his shots and I thought, good, because after Drew’s second DPT shot he had cried for a very long

time.

When I got home from work, Scott told me that Drew had been

sleeping most of the day and was still sleeping. Scott went to work

and I woke up Drew so he could eat, but he went back to sleep

again. When Scott got home from work later that night, he was

passing our boys’ room when he heard a strange, rasping sound

coming from the room. He checked on Mike, who was fine, and

then realized that the sound must have come from Andrew’s crib.

When he got to Andrew’s crib, he had the shock of his life. Our

little boy wasn’t breathing and he was as pale as a China doll.

Scott yelled for me to come and asked me, ‘‘What is this?’’ All I saw

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was my baby laying in his father’s arms as limp as a rag doll and

as white as a China doll. I ran downstairs and grabbed the phone

and dialed 911, but I was in such shock that I forgot my address

and street name.

Scott followed me and handed me Andrew, and I realized for the

first time that my baby wasn’t breathing. I did CPR on him, and

after the second breath I gave him, he took in a deep breath himself. The color came back into him and he appeared to be sleeping.

The fire department came. Half of the men worked on Drew

while the other half followed me to the boys’ room. I showed them

Andrew’s crib and the puddle of fluids we found him lying in. One

fire fighter told us that he believed that Drew had had a convulsion. He said Drew was very warm and asked for some ice bags to

cool him down. They told us Andrew would have to go to the hospital.

Andrew was transported to the hospital in an ambulance, and by

the time he got to the hospital, he was in the middle of another

violent convulsion that was so bad they wouldn’t let me in the room

with him. Finally he stopped convulsing and the doctors explained

that this may be the only time he convulses, and it may never happen again.

One month later, he was crawling on the floor when all of a sudden he collapsed and began to jerk his arms and legs while his

head went backward and his neck stiffened. I grabbed him and told

Scott to call 911, and at the hospital they explained to us again

that sometimes children have seizures and they grow out of them.

Between the ages of 6 months and 31⁄2 years old, Andrew had 84

seizures, the shortest being 15 minutes and the longest being 11⁄2

hours. Almost always, Andrew would run an unexplained fever

with the seizures even though he wasn’t sick. One doctor told me

the fevers he ran with his seizures was because his body’s thermostat had been damaged, and his body could not regulate his temperature like it should.

Still, with all those seizures, the miracle was that Andrew

learned to walk and talk. At 3, he could count up to 20; he knew

his colors and shapes. We learned to live with his seizures even

though we always lived in fear that 1 day he would have a really

long seizure that would damage our bright, loving, intelligent little

boy.

On the night of September 8, 1995, our worst nightmare came

to life when Andrew went into a seizure that lasted 41⁄2 hours.

Standing by helplessly as our son seized for 41⁄2 hours while his

temperature climbed to 108.8 degrees is an experience no parent

should ever have to go through. When Andrew finally stopped seizing, we were allowed to see him in the ICU. To our horror, we saw

a child double the size he was when he came into the hospital.

When we asked what happened, they took us out of his room. At

7 a.m., a doctor told us that Andrew’s kidneys and liver were failing.

When we finally got to see our son again, he looked like another

child. We couldn’t hold him, because he had a dozen tubes hanging

off of him. A special bed rotated his body, keeping his body at one

temperature and massaging him all at the same time.

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At 9 a.m., we were told by the doctor—and I will never forget

those words—we were told: ‘‘Your son is dying, and so that you understand what I am saying, he will die before 12 p.m. If you want

to see him alive, you better call anyone who wants to see him now.

Here is a phone you can use. Are you OK? Mrs. Clements, are you

all right?’’

Not knowing what to say, I said ‘‘No, not my baby’’ over and over

again. ‘‘He didn’t go through 84 seizures to die. God has a great

use for his life. He didn’t bring him through all these seizures to

die now.’’

Every organ in Andrew’s body was damaged and was functioning

at only 10 percent. Andrew didn’t die that day as the doctors said

he would. By the grace of God, he hung on to life. On September

11, Andrew slipped into a coma.

Andrew was in the hospital for 4 months while we waited for

him to come out of his coma. During that time, I called our lawyer,

Victor Harding, to tell him what had happened. Mr. Harding was

representing Andrew in the U.S. Court of Claims which hears vaccine injury compensation cases, and he told us that the Government had offered us $350,000 to take care of Andrew.

All I could think of was how unfair it was. My son is fighting for

his life. He may die, and if he lives, we don’t know what kind of

condition he will be in. And the Government is telling us that all

Andrew is worth, if he lives, is $350,000. That amount isn’t going

to begin to be enough to care for a severely brain injured child for

the rest of his life. I told our lawyer, ‘‘You can tell those Government lawyers where they can file that offer.’’

As you can see, Andrew did live. He fought bravely to live. Andrew is a hero, and now it is my job as his mother to fight for him

to have the best kind of life that I can give him.

Andrew can’t walk or talk; he can’t eat or drink; he has to be fed

through a tube in his stomach. Sometimes we give him tiny tastes

of food. I will put a drop of apple sauce or pudding on the tip of

my finger and put it on his tongue, but it can’t be too much or he

could choke because he can’t swallow properly. His body is 7 years

old but his brain is that of a 3-month old.

I was a good parent. I did what the Government and doctors told

me to do, and I gave my son the DPT vaccine. And now he is crippled. His life has been sacrificed, and instead of being treated kindly and fairly by the Government’s Vaccine Injury Compensation

Program, we have been treated unkindly and unfairly.

You may be wondering how we found out about the Vaccine Compensation Program. It wasn’t from anyone in the medical field. We

found out from a stranger who had heard about what happened to

Drew. Her son died from the DPT vaccine. She referred us to a

lawyer and sent us information about the DPT vaccine.

Reading the information, I felt like I had just been transported

into another world, a world that I didn’t believe could exist in our

country where the Government keeps such information from us

that could help us protect our children from becoming retarded. I

didn’t know that when Andrew screamed for hours after his second

DPT shot at 4 months that it was a warning sign that shot might

not be good for him. I didn’t know that in 1992 there was a safer

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DPT shot called DtaP vaccine that causes fewer reactions. I wish

Andrew had a chance to get the DtaP vaccine instead of the DPT.

When we met with our lawyer, Victor Harding, he told us about

applying for the Vaccine Injury Compensation Program and what

to expect from the Government. He said that a lot of children like

Drew are denied compensation or offered so little money that it

wouldn’t be enough to take care of him for the rest of his life. Like

I said earlier, when my son was on what we thought was his death

bed, the Government offered us $350,000. We turned it down and

proceeded to the next step.

We had to fly to Washington, DC, for our compensation claim

hearing in the winter of 1998. My stomach was full of butterflies

when I gave my testimony about what happened to Andrew on the

night of August 6, 1992. I stayed for 5 hours of the 10 hour hearing

and then went back home to care for my son. My lawyer was there

for the second half of the hearing on the following day.

In the end, the Government turned Andrew down for compensation. There would be no money to help us care for our son. The

Special Master told us that if we had applied for compensation a

year earlier, she would have found in our favor but because of the

table change, there was nothing she could do but find in favor of

the Government.

That angered me, and it still does anger me that this table can

be changed by the Government after Congress put the table in the

law to help children like Andrew get compensation. That table

change sure wasn’t for the betterment of the families who go

through horrific life changes due to vaccine injuries. The Government forces us to give our children these vaccines and then when

something goes wrong, too bad, you are on your own.

The Special Master told us to appeal, but where is the logic in

doing that if the rules are still the same? We will take our chances

with the vaccine manufacturer in court. Because if we don’t, what

is going to happen to Andrew?

The doctors told us Andrew could live to be 25 or even 40 years

old. We want to care for him as long as we can. We don’t want him

to be put into an institution where they won’t do for him like we

can do for him. To care for him the right way, our home needs to

be wheelchair accessible, and we need a lift to get him into a van,

and we need to be able to afford to buy all the medications and

supplies he needs after he turns 18 years old. We just want enough

money to care for him the right way, because no amount of money

could ever really compensate Andrew or us for what the DPT shot

took from him.

Once again, thank you for listening to what has happened to my

son and our family, and God bless you.

[The prepared statement of Ms. Clements follows:]

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Mr. MICA. Thank you for your testimony, and I would like to now

recognize Linda Mulhauser, who is a petitioner and mother of an

injured child from New York.

Mrs. Mulhauser, you are recognized.

Ms. MULHAUSER. Thank you.

My son Stephen is sitting in front of me so that he can do as

much lip reading as possible, and I am wearing an FM microphone

to help elevate my voice for him. The interpreter was not available

for today’s meeting.

Chairman Mica and members of the Government Reform Committee, thank you for your invitation to appear at today’s hearing

to tell of our family’s experience with the Vaccine Injury Compensation Program.

Our son, Stephen, now 17 years old, was seriously and permanently injured by a DPT vaccination at 31⁄2 months of age. Born

healthy and full-term by natural childbirth, Stephen received the

highest Apgar score ratings of 9 and 10. At 7 weeks of age, Stephen

received his first DPT vaccine. We were reassured by his pediatrician that the swelling at the injectionsite, among other changes we

noted, was only a mild reaction and of no concern.

Following the pediatrician’s advice that the benefits outweighed

the risks, Stephen was given and reacted severely to his second

DPT shot with over 9 hours of high-pitched screaming and high

fever.

During the next couple of days, Stephen’s eyes began wandering

independently of each other and then spasm. He could no longer

roll over or reach out to play with his crib gym, because his hands

were fisted and held at his shoulders.

Over our concern, Stephen was then given his third dose of DPT

vaccine in half doses at 51⁄2 and 61⁄2 months of age. His pediatrician said that he must have this vaccine in order to attend school.

We later discovered during our compensation hearing that from

the day of the second shot in 1982, Stephen showed failure to

thrive as his charted growth plummeted. Stephen’s brain had all

but stopped growing during the time period he was receiving his

DPT vaccines. He remains affected with fine motor and gross motor

difficulties, posturing, language-based learning disabilities, visual

perception issues, behavioral problems, and profound bilateral

hearing loss. He requires special schooling, assistance with simple

daily living skills, constant adult supervision, and numerous therapies.

Having your child injured by a vaccine that is supposed to protect him is devastating. Our experience of going through the compensation system only added insult to that injury. After 5 years of

preparation for a civil suit through depositions, ready for trial, our

attorneys informed us that they had become obligated to advise us

to put a stay on our case and apply for Government compensation

prior to a 1990 deadline date. It was supposed to be a simple and

expedient process, taking about 18 months, with decisions to be

made by special masters without a trial. We were advised that we

could go back to the lawsuit if the desired outcome was not

reached.

Nine months later, we had our hearing in a New York Federal

courtroom, requiring preparation and giving of testimony, including

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cross examinations. Expert witnesses were called for both sides.

Two months later, the special master determined that Stephen was

in fact injured by the DPT vaccine, as described within the guidelines of the vaccine injury table.

Although we considered this first step of the process to have been

timely and professionally managed, it seemed only to lack a jury

to be a traditional court trial.

The next step of the process was to determine an amount of

money to be compensated. We already had a life care plan in place,

because we were ready to go to trial before entering the Compensation Program. Instead of working with us to determine Stephen’s

appropriate life care needs, the Department of Justice’s attorneys

sought for years to trivialize the extent of Stephen’s vaccine injuries and to argue for irresponsibly insufficient funds to support a

reasonable quality of life.

After 4 years of such negotiations, we needed to request another

hearing to come to settlement requiring further testimony from

ourselves and Stephen’s life care planner. It was determined on the

spot by the chief special master that the life care plan the DOJ’s

attorney and life care planner submitted was indeed unrealistic

and ordered specific actions to be completed within 2 months.

This hearing in and of itself, again, was handled professionally.

However, 2 months turned into 4 before an agreement was signed.

Further delays ensued to correct a significant math error relative

to the initial payment. The agreement was then filed at the end of

the 90-day filing period. The stipulation then required that we become legal guardians of our own child, causing further delay before

any checks would be issued by the annuity company.

From the time we applied to the Vaccine Injury Compensation

System to the time we were finally able to access the funds, 61⁄2

years had gone by. Our savings disappeared as we paid for therapies not covered by our insurance, hearing aids, and special schooling, among other extraordinary expenses. Under the guidelines of

the program, families are not reimbursed for any past expenses.

We were very fortunate in that the law firm who represented us

continued to fight on Stephen’s behalf far beyond any financial

gain. In fact, the single payment of $30,000 allocated for attorney’s

fees in pre-1988 cases only covered the expenses incurred in preparation of our two hearings. The law firm itself received nothing for

its efforts of representing Stephen over a 10-year period.

Our attorney has described the hearing process as a ‘‘full-out liability case.’’ Once our case was won, he then had an item-by-item

fight to obtain even the smallest of needs on Stephen’s life care

plan. Concessions were only made on small items. Much time was

spent by the DOJ attorney forcing the discussion of petty matters,

such as whether Stephen would benefit from the use of a $10 special needs doorknob—one was allowed throughout his lifetime—

rather than getting down to serious matters dealing with the quality of Stephen’s future. Deadlines were often extended.

In our view, the recommendations of the DOJ attorney and Government life care planner assigned to our case were unrealistic and

irresponsible. For example, to determine the value of residential

care, they specified a residential center only in its planning stages

or a charitable group home with no day services and a wait list of

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over 1,500 persons. We were given a ‘‘take it or leave it’’ final offer,

which still did not adequately address Stephen’s needs. This

prompted our request for the second hearing, which took place 10

months later.

We entered into negotiations for Stephen’s life care with the belief that, unable to support himself, his needs would be met, and

his future would be sufficiently secure so that he could live as independent and normal a life as possible. We were mistaken. Our experience was a totally exhausting and extremely adversarial process of nickel and dime arguments.

On the Government’s behalf, every effort was made by the DOJ

attorney to hold on to as much of the fund as possible. This included an attempt to establish a reversionary trust requiring any

moneys not spent during the course of each year to be returned to

the Government. Such practices place at risk the future care and

security of every vaccine-injured child.

The DOJ attorney continued to act as if he was still fighting a

case, attempting to minimize the award which he had previously

fought to avoid. This conflict of interest deadlocked negotiations

and added years to resolving our settlement. After a decision is

given that a child should be compensated, DOJ attorneys should

step aside and allow others with input from life care planners and

families to determine the projected needs of the individual throughout the balance of their lifetime.

As compensation is not retroactive to the date of the decision,

each additional year of bargaining is 1 less year to be compensated.

This places further undue hardship on already emotionally and financially strained families. Our perception is that the program relies on this tactic to force families and their attorneys to accept less

than adequate settlements, which would provide optimal treatments for their vaccine-injured child. Once the determination has

been made that an adverse reaction was incurred, both sides

should be working together in the best interest of the child.

The all out effort, time, and expense required to successfully negotiate the Vaccine Injury Compensation Program prompted our

major law firm to never accept another vaccine injury case.

We are further concerned that life care plans used to determine

settlement amounts are forwarded to annuity or trust companies

with the stipulation labels remaining. In our experience, copies of

the life care plan have also been requested by courts and banks.

A child’s needs will inevitably vary. Type or frequency of therapies

can and do change. New treatments become available. Labels remaining on life care plans used to determine payment schedules

leave open a real risk that at any time someone might withhold

funds if moneys aren’t spent specifically as tagged. We are extremely uncomfortable that an individual as far removed as a bank

clerk can potentially have a say over Stephen’s care, because a

treatment is not listed on his life care plan.

Every family who has gone through this system faces the same

threat to their child’s welfare. Might I suggest that such labels be

removed in the future before sending out the plan and that a letter

be issued to clarify the ability of legal guardians to utilize funds

in the most appropriate manner for the injured individual in their

care.

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As parents, we did everything in our power to provide the love,

nurturing, and care to ensure a bright future for our first-born

child, a life full of dreams and promise. Part of that care was to

protect him from harm and life-threatening diseases. We believed

we were protecting our son when we took him for his baby shots.

Instead, his life and ours have been changed forever.

Each day is a challenge, and we try to meet that challenge to

make things a little better. My hope is that by our presence here,

today’s challenge will make things better for the many families of

vaccine-injured children who are in or who are attempting to enter

into the Vaccine Injury Compensation System, and for those who

have been rejected by the system following changes to the vaccine

injury table.

Thank you for the opportunity to share our experience and to express my concerns.

[The prepared statement of Ms. Mulhauser follows:]

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Mr. MICA. Thank you for your testimony. We will withhold questions until we have heard from all the panelists.

Next is Mr. John Salamone, and he is president of Informed Parents Against VAPP.

You are recognized, sir.

Mr. SALAMONE. Thank you, Mr. Chairman, members of the subcommittee. I appreciate the opportunity to talk with you today regarding legislative and policy options for improving the Vaccine

Compensation Program.

Before offering specific testimony concerning outlined areas for

improving this program, I would like to state for the record that

I have served as vice chair of the HHS Advisory Commission on

Childhood Vaccines and currently serve as an unpaid consultant to

the Subcommittee on Vaccine Safety for the National Vaccine Advisory Committee.

But more importantly, I am the father of David, a 9-year old

with polio contracted from the oral polio vaccine. As David’s dad

and as president of Informed Parents Against VAPP, also known

as IPAV, a group of families who suffer from oral polio vaccine injuries, I worked long and hard with immunization advocates to

move this country toward an all-IPV schedule or a killed virus

schedule.

I am a supporter of immunizations. I have seen first hand in my

life the diseases that we can now prevent and believe that we must

maintain a strong immunization system—the safest one possible.

With my son and others in IPAV having paid a huge personal price

for mass immunization, I have also become very familiar with the

National Vaccine Injury Compensation Program.

The first topic I was asked to address concerns changing the adversarial nature of the Compensation Program procedures and the

hearing process. Given the choice between the program and personal injury lawsuits, the program wins. However, there is room

for improvement. In their current form, the procedures are at times

adversarial and need to become more user friendly.

Some suggestions to improve the process include: reevaluating

the procedures to take into account the literacy level of most applicants. In its current form, either on the website or in the information packet, the language cites legal requirements and can often

put off those unfamiliar with such legal terms. In short, put it in

plain english.

Provide simple and clearly defined steps an applicant must go

through in order to be considered for an award. This will assist applicants in working through the process and lead to a better understanding on their part of what their responsibilities are.

It would be ideal if new applicants could be provided with a

counselor who can provide support through the application process.

Most of the families who are dealing with vaccine injuries are simply too overwhelmed. They need the kind of assistance that comes

from a person, whose job description includes compassion as a requirement.

The counselor can be empowered to provide references where applicants can get legal aid. Perhaps a bar association or other third

party group can be asked to provide this special and much needed

service.

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The second area is reforming the evidentiary and adjudicative

standards for determining compensation. From my experience and

those of our families, I feel that the evidentiary stage is generally

fair and runs smoothly for most applicants.

An overall comment, however, is that the government trust of $1.4 billion is guarded too well. The coffers need to be opened to

provide the kind of humane service people in vaccine injury situations not only need but deserve. For example, the damages phase,

to use the common term, can become more flexible in allowing for

special circumstances. We have had families who have gone bankrupt trying to meet their children’s medical and emotional needs

while going through the system.

The Government can also provide greater clarity with regard to

future lost wages. Some suggestions that come to mind include: administering intermediate funds to those in need based on good faith

and a reasonable basis for claim; including family counseling expenses and reasonable fees and costs associated with the establishment of a guardianship or conservatorship; extending the current

statute of limitations from 3 years for injury claims and 2 years for

death to 6 years, and creating a specific method or formula for calculating lost earnings under VICP that is easily adaptable for individual use.

The final area of review is ensuring the level of funding to meet

future needs. Current funding is not in jeopardy and should certainly be maintained. As future vaccines are created, these need to

be added automatically to the injury table with assignment of appropriate excise tax. Let me repeat: It is not about funding; it is

about access to funds for those who need it. If greater funds would

equate to better services for applicants, then I would say, yes, provide more funds earmarked for those services I outlined earlier. If

the committee takes action that will enable larger awards, then the

criteria for what is covered under an award would need to be reevaluated.

I firmly believe in the VICP. It has done the best job it can under

its current design to fulfill its purpose. I have been impressed with

the dedication of those I have worked with in the program over the

past 6 years. I believe, though, that even they would admit that

improvements can and should be made to ensure that this program, which has served us well for a decade, can continue to meet

the needs of those who sacrificed themselves for a universal vaccine

program.

Thank you, Mr. Chairman.

[The prepared statement of Mr. Salamone follows:]

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Mr. MICA. Thank you. Thank all of our witnesses for their testimony this morning.

I have a couple of questions, if I may.

First, Mrs. Clements, I think you have been denied participation

in the fund because of the original injury table being changed, and

I believe you testified you felt this is grossly unfair. What would

you recommend as far as a process that you think would be fairer,

and, again, what about individuals like you who have been denied

the opportunity to participate because of these changes, you think

that Congress should take some remedial action to allow your participation?

Ms. CLEMENTS. Basically, when we first applied for—when I first

got information on the adverse reactions, I got the papers, and my

son fit the—if you want to say qualified—for getting compensated.

Then, as I said, the table changed, and all of sudden there is just

no one, basically, it sounds like could possibly be compensated because of the way they changed this table.

And if they could put it back to the way it was, more families

could be compensated or make it, as Mr. Burton said, stop making

it impossible and stop making it where we have to go in and fight

to prove that our child reacted. When my son reacted in 15 hours

to it, and we have 72 hours at that given time when we first started that if he seized within 72, it is a reaction from the DPT shot.

Then all of a sudden it is no longer on the table.

I had a great problem with them taking the seizures off the

table, because I know a high percent of reactions are seizures from

the DPT shot, and that, to me, just showed a sign of saying, ‘‘We

don’t want to pay anyone anymore, and we can get rid of this section of people or children that react,’’ and if they could just look

into it deeper and, like Mr. Burton said, investigate it in the longterm and not do a couple weeks, a couple months study, because

our children are getting these shots up until possibly 6 years old,

and we don’t know what can happen at 6 months. The friend of

ours whose child died, died at the fourth shot.

So, the other thing of giving warning signs, my son had two prior

warning signs to it, but because my doctor and a lot of doctors don’t

tell us these adverse reactions, I didn’t know. My son may not be

in this condition if I would have known that the, if you want to say,

the junkiness that developed after the—when he was 2 months old.

He had a rattle in his chest, and I kept going to my doctor saying, ‘‘Something is wrong. Something is wrong’’ right after he had

his DPT shot, and I was given the normal of ‘‘Well, newborns make

that sound.’’ I go in for the 4-month old, and he does the excessive

crying. And I am not told that is an adverse reaction, so I go in

with the 6-months, and now I have a son who has a seizure disorder and ultimately puts him in this condition. Now, I could have

been—that could have been eliminated if I would have known the

warning signs ahead of time.

So, it is something to make sure that the doctors are forced to

give out that information, that it is not a—well, as I view it—a

cover up or a hiding, to go into a long study of what is going on

with children that react, because some children don’t react on the

first one.

42

Mr. MICA. Have you had access to any other legal remedy? Have

you pursued a suit against the manufacturers or——

Ms. CLEMENTS. At this present time, our lawyers are looking into

the steps of—or looking into going after the pharmaceutical company themselves. They figure there are ways of going after the

manufacturers.

Mr. MICA. To date, to deal with the problems you have incurred,

how have you had to deal with that financially—just all your family resources or some other——

Ms. CLEMENTS. Originally, when Andrew started out with his

seizures, it was financially coming through us, and then we were

told that we could go and apply for SSI, and that would help take

care of the medical bills and things like that. So, probably within

a few months, about 6 months we had to wait, and then SSI kicked

in, and it started paying the bills. But, originally, we paid the beginning of those bills for probably the first 6 months of his reacting

to it.

Mr. MICA. Ms. Mulhauser, it took you, what is 61⁄2 or 71⁄2 years

to receive compensation?

Ms. MULHAUSER. It took 5 years to finalize all of the stipulation.

It took another year and a half to go through the court system to

establish legal guardianship. So, the annuity company would not

release the checks until we had proof of legal guardianship, and it

was a process we couldn’t start ahead of time, because the guardian courts required the stipulation to be filed.

Mr. MICA. Based on your experience, how can we speed up this

process?

Ms. MULHAUSER. Like I testified earlier, I believe that if both the

Government and the parents come to the table with the child’s best

interests instead of fighting over the cost of one item or another or

whether it is going to cost $5 or $10, the process would speed up

quite a bit.

I think we could have taken 3 years off of our compensation time

just by letting the life care planners who are qualified to determine

life care needs, with the doctors’ reports, the educational reports,

the parent input—there are plenty of resources that are available

that a mediator, say, who specializes in the life care planning of

individuals with disabilities, could bring that process to a conclusion much sooner than having high-priced lawyers arguing over

items.

Mr. MICA. Thank you.

Mrs. Mink.

Mrs. MINK. Thank you, Mr. Chairman.

The testimony of all the witnesses on this panel is very, very provocative, and I hope will be utilized to encourage this committee to

make some very important changes to the existing law.

Mrs. Clements, what bothers me in the situation that you found

yourself in, with respect to the symptoms that occurred immediately after the shots were given to your son, that no one explained to you at that point that those were suggestive of adverse

reactions to the vaccination and that you relied on your physician

to be able to make an appropriate reading as to what was going

on inside your child’s system.

43

I take it from your testimony that your physician did not provide

you with such a forecast or analysis of what was going on. Is that

correct?

Ms. CLEMENTS. Correct.

Mrs. MINK. Then it seems to me for the compensation system to

insist that you as a parent, non-medical professional, be able to

make a decision to halt the Vaccination Program, which the Government was insisting that every child have, is perfectly illogical.

There is no reason for a parent to know when to insist that the

Government stop the vaccination procedure. The physicians, on the

other hand, have the knowledge and the training, or should have,

and be able to make those decisions. Don’t you agree?

Ms. CLEMENTS. Yes.

Mrs. MINK. So, given that circumstance, it would seem to me

that one of the things that the committee should look at is the responsibility of the medical profession in each of these cases. Warnings should have been given. The medical profession should exercise sound judgment, and in the absence of exercising that sound

judgment, compensation should be automatic. I mean, that is my

general feeling.

And to hear your testimony that such technical things as a statute of limitations, that your filing was 1 year late, or that the technicalities of the table had changed so as to disqualify your claim

is absolutely unacceptable in tort law.

I happen to be a lawyer. It is always the incident of the injury

that establishes the date of the claim. It was through no fault of

your own that you were not apprised of your ability to stop this injury from occurring and becoming more serious. The compensation

concept of the Federal Government should be an automatic processing of the claim, because certainly there could be no other justifiable reason for your child being in this serious condition that he

is in. The medical profession acted inappropriately and this injury

could have been prevented.

And given those circumstances, the compensation approach

should be categorically in your favor, since there could be no possibility of negligence on your part. It is not the case of trying to find

blame on the medical profession, but certainly to deny compensation in your case goes against all semblance of justice and equity

in this country.

So, I would hope that the committee would be able to take your

testimony and your statement and correct that. And certainly with

respect to the timeframe, the Government should have a statute of

limitations where if they fail to act within a reasonable time, that

the compensation claimed by the victim’s family ought to be automatically adjudicated by some third party.

I think that since the Vaccination Program is one that is imposed

by the Government for the public safety, that we ought to impose

upon the Government strict regulations with reference to the protection of the parties involved, and, Mr. Chairman, those are my

views.

Thank you.

Mr. MICA. Thank you.

I would like to yield now to the chairman of our full committee,

Mr. Burton.

44

Mr. BURTON. Thank you, Mr. Chairman.

I am not going to ask but one question. I have to leave to go to

a luncheon, but I will be back for further—for another part of this

hearing.

I want to express to the parents my sorrow and all the parents

across the country that have experienced what you have. I have

similar feelings for my grandchildren, and may the good Lord bless

you and your families for what you have gone through and what

you are going to go through the rest of your lives.

I would like to just make a couple of comments. The reason that

this fund was set up, as I understand it, is because the pharmaceutical companies were concerned about massive lawsuits and how

it might adversely impact their industry and how many of those

pharmaceutical companies smaller in nature, and even the large

ones, might go out of business if excessive lawsuits, because of adverse reactions, occurred.

And, so the Government and Mr. Waxman justifiably sat down

with them, and said, ‘‘OK, we are going to work this out so that

there is a non-adversarial process that will take place where people

will be compensated fairly, and you will still be able to protect the

pharmaceutical companies.’’ And this fund of 75 cents a shot was

established to take care of that.

Now, we find it is an adversarial relationship; that people have

to fight to get that money; they can’t get lawyers to take their

cases—and I know; I am speaking from personal experience now.

We can’t find many lawyers that even want to look at this. So, this

adversarial relationship that has been created should not be happening, because that was not the purpose of the fund.

Now, some people have said to me privately that they are con- cerned that even though we have $1.1 billion in that fund, that the

fund may be depleted if they aren’t very careful. Well, my view is

if it is a non-adversarial situation we are looking for, then if we

have to increase the cost per shot to $1 or $1.50, double it, to make

sure that these people are adequately compensated for the tragedy

that they have to endure, then we should do it. But there should

not be this kind of a problem.

And I intend to be back for the gentleman who works for the

fund and the people at the Justice Department, because I am sure

Congress didn’t intend that, and if they are trying to protect that

fund, then that is baloney. We can always raise the amount. And

I am not for tax increases, but I am for making sure that people

who suffer like these people have suffered are fairly and adequately compensated, because it wasn’t their fault that this happened.

The second thing that concerns me is that my son-in-law is a doctor, and I have talked to him about this, obviously, because it is

our family that is involved. And I ask him about shots, and he

says, ‘‘Well, we get guidelines from the Food and Drug Administration and from the Health and Human Services, and unless it is approved by the FDA, then, you know, I am very careful, and I

don’t—’’ So, they rely—the doctors rely, in many cases, probably in

most cases, on the judgment that is coming out of their associations, which is coming from the FDA. And, so if we are not getting

enough information, then it seems to me that the Government

45

health agencies must be more forthcoming to the physicians so that

they could be more forthcoming to the patients so that everybody

will know the risks involved.

That hepatitis B shot that my granddaughter took, that almost

killed her, would not have been administered had I known the

risks or my daughter knew the risks. My grandson got five shots

in 1 day. You know, sometimes I think it is an overload of the system, like if you put too many plugs into an electrical socket, you

are going to blow the breaker switch or you are going to—if you

have an old-style home, you are going to have the fuse blown. And

we are loading these kids up with 25, 30 shots between the time

they are born and they are 5 and 6 years old before they go to

school. And we need to know from HHS and FDA and our health

agencies, through our doctors, what the risks are, and the parents

need to know that so we minimize the kinds of problems we are

talking about here today.

So, those are my views. I think I would just like to ask you, Mr.

Salamone one question, and your son suffers from the polio vaccine,

the live polio vaccine. You were talking about making sure that

dead viruses are used. Now, is there any indication from your research or from talking to scientists and physicians that if we use

dead viruses that the risk is minimized even though they may get

several vaccines?

Mr. SALAMONE. The only cases of polio in the United States for

the past 20 years have come solely from the oral polio vaccine.

Mr. BURTON. The live vaccine.

Mr. SALAMONE. That is right. And, so in answer to your question,

I don’t have any information to indicate anything specific regarding

the killed virus, but I guess the facts are that polio in the United

States, while we think that it has been eliminated, in reality, we

have been creating it by the very vaccine designed to prevent it,

and that was the oral polio vaccine. And I am pleased to note that

as of January 2000, they are recommending now—the CDC is recommending that the oral polio vaccine no longer be part of the regular vaccination schedule finally after 5 years, I might point out,

of a lot of testimony.

Mr. BURTON. And I wonder how many people suffered. Do you

have any idea how many people—— Mr. SALAMONE. Well, on the books, they say between 8 and 10

a year, but, quite candidly, virtually every family that we deal with

has been misdiagnosed. And in the case of my son, it took them almost 2 years to finally put the pieces together and figure out that

he didn’t have half of his immune system, and that is why he got

polio as a result of the vaccine.

Mr. BURTON. If I might ask just another question of this witness,

Mr. Chairman.

So, the people from HHS and the people from the health agencies

have known for how many years now that the live virus caused

this problem?

Mr. SALAMONE. Oh, I venture to say that the health industry has

known for decades that you can get polio—— Mr. BURTON. Well, let me—my time is running out. So, they have

known it for decades, and there was an alternative to that—the

dead virus—that could have prevented polio, is that correct?

46

Mr. SALAMONE. That is right. A safer, killed virus was available.

Mr. BURTON. And yet they went ahead and let the American people take the more dangerous virus for, you say, for at least a decade or so.

Mr. SALAMONE. It was just a bad, old habit that went back to

those days decades ago.

Mr. BURTON. Well, I am not so sure. And one of the things that

we want to investigate is whether or not the pharmaceutical companies, who have a huge investment in this, have influence or

undue influence on the departments of health in this country. If

you know that a virus that is live causes this kind of damage to

a young child, whether it is polio or anything else, and if they continue to use it when there is an alterative—for instance, the DPT

shot is still being used today, and they have a DPaT shot that is

safer, and when I asked people at the hearing we had not long ago,

they could not explain to me why the DPT shot is still being used.

The only thing that pops into my mind is there is money involved,

and if there is money involved, why are HHS and the FDA allowing that to continue to be used? And, so we are going to check all

that out.

It sounds like a similar situation with the polio virus vaccine. We

are going to look into all that, and we are going to get the records

of all the people who are in the decisionmaking process at the

health agencies; we are going to get those records. We are going

to go back and find out where the money came from when they go

to speak. We are going to go back beyond the organization that

puts the meeting together where they speak and find out if the

pharmaceutical companies are underwriting all that and if they are

paying honorariums for these people. And if that is going on, there

are going to be some changes made in the way HHS and the FDA

do their business. And we are going to check everybody out, everybody.

Mr. MICA. Thank the chairman.

If I may, Mr. Kucinich, can I recognize Dr. Weldon, and then I

go to you? Would that be acceptable? Thank you.

Dr. Weldon.

Dr. WELDON. Thank you, Mr. Chairman.

Ms. Mulhauser, I was looking at your resume. You had a career

in fashion design prior to your son’s illness coming along, is that

right?

Have you been able to work in that field at all or have any income since your son’s illness arrived?

Ms. MULHAUSER. No, I have not worked professionally since my

son’s vaccine injury.

Dr. WELDON. How much of your time is consumed with caring for

your son, would you say, on a typical daily basis?

Ms. MULHAUSER. It is 24 hours. I mean, he sleeps at night, but

even when he is in school, I am still responsible for overseeing his

therapies, scheduling his doctor’s appointments——

Dr. WELDON. Can you give me an idea——

Ms. MULHAUSER [continuing]. Paperwork involved with the annuities and the checks coming in, annual accountings, financial accountings, petitions for maintenance to use the fund that has been

47

allocated for him. And I do a lot of volunteer work related to his

school and the rights of the disabled, the rights of the deaf.

Dr. WELDON. And you have another child, is that right?

Ms. MULHAUSER. Yes, I do.

Dr. WELDON. Is it safe to say that the vast majority of your time

since your son’s illness has been devoted to petitioning the Government for compensation, caring for him, and that has essentially

precluded you from working in your field?

Ms. MULHAUSER. Yes, that is true.

Dr. WELDON. I notice there is a gentleman with you. Is he your

husband, attorney?

Ms. MULHAUSER. My husband.

Dr. WELDON. Your husband. Your husband has a job, I take it?

Ms. MULHAUSER. Yes.

Dr. WELDON. And I would imagine that the vast majority of his

free time when not working has been devoted to supporting your

son as well.

Ms. MULHAUSER. Yes.

Dr. WELDON. And when you apply for compensation, you don’t request any compensation, and you are not eligible to get any compensation based on your lost income and the time that you have

devoted to caring for your child. Is that correct?

Ms. MULHAUSER. That is correct.

Dr. WELDON. OK.

Ms. Clements, I want to ask you the same line of questioning.

I see you brought your son with you today, and there is a lady with

you. I assume she is a relative of yours?

Ms. CLEMENTS. My sister.

Dr. WELDON. Your sister. I assume for you to go out anywhere

and do anything, you have to get either a family member to sit in

and help you or to have somebody paid come in and help you? Is

that correct?

Ms. CLEMENTS. I have someone in my family come in or take him

with me.

Dr. WELDON. OK. And as you have been trying to work through

the Vaccine Compensation Program, you are trying to get funds

just to take care of him. You are not petitioning for any loss of your

time, any pain and suffering on your part for this case. Is that correct?

Ms. CLEMENTS. Correct. There is nothing that can—there is no

amount.

Dr. WELDON. Just one additional question I have for you. You

mentioned in your testimony that you were considering or you are

in the process of filing a claim against the pharmaceutical company

directly. Is that correct?

Ms. CLEMENTS. Correct.

Dr. WELDON. The purpose of the Vaccine Injury Program was because the vaccine manufacturers said they were going to get out of

the business because of the huge number of claims that were being

filed against them. One of the concerns that I have is that the program is so adversarial that individuals such as yourself will start

the process anew of filing claims against the pharmaceutical companies, and then we can be right back to square one that the sysVerDate 11-MAY-2000 09:43 Nov 27, 2000 Jkt 000000 PO 00000 Frm 00051 Fmt 6633 Sfmt 6633 C:\DOCS\66079.TXT HGOVREF1 PsN: HGOVREF1
48

tem has truly failed us so badly that the pharmaceutical companies

are getting out of it again.

Would you say that it is a correct assessment that people with

situations such as yours have no choice and that they are going to

start filing claims against the pharmaceutical companies?

Ms. CLEMENTS. Yes, I would say that is correct.

Dr. WELDON. Thank you, Mr. Chairman, or Madam Chairwoman.

I yield back.

Mrs. MINK [presiding]. Thank you.

I recognize the gentleman from Ohio, Mr. Kucinich.

Mr. KUCINICH. Thank you very much, Mrs. Mink.

There are a few things that emerge when one views this very important public policy issue. First of all, the role of Congress. The

question has been asked, and it should be put before this committee, whether or not Congress has essentially delegated away to

HHS what is a legislative function.

With respect to the National Institutes of Health, it appears to

me that there absolutely is a need for more research of the adverse

vaccine reactions, because what we are dealing with here is a system that provides for compensation for those who have had an adverse vaccine reaction, but I think it is incumbent upon us not to

simply take it for granted that those reactions will occur; that more

emphasis needs to be put on research to make sure that everything

is being done to try to limit the amount of reactions which are occurring.

The people who have come here today—and I have had a chance

to review the testimony—certainly have pointed stories, and I

think all Americans can sympathize with what happens when a

perfectly normal child is given a vaccine and ends up with a catastrophic injury. And we have to care about that. We have to be attuned to the kind of suffering that occurs. And, in a sense, there

is no amount of compensation that can genuinely help a family and

an individual who has gone through that kind of trauma and will

continue to go through it through their entire life.

The thing that concerns me, Madam Chair, is that I understand

the existing law still permits the Department of Justice to seek cost

reimbursements from unsuccessful petitioners who appeal their

case to the U.S. Federal Court of Appeals. Is that correct, Madam

Chair and Mr. Mica?

See, that is one of the areas where this Congress, I think, can

intervene on behalf of those families who have suffered. It just

doesn’t seem fair that one should have to go through a route of trying to seek compensation or increased benefits and cost reimbursements, and then if you happen to lose, to have the Department of

Justice come after you for the cost of an appeal to the U.S. Federal

Circuit Court of Appeals.

Again, I want to thank the chairman, Mr. Mica, for his diligence

on these issues, and the information that you have already brought

forward as a result of this committee’s work indicates that reforms

are needed, and I am sure that with the Chair working with Mrs.

Mink and this committee, that we are going to try to find some relief that will—it will never make you whole again in terms of the

damage that has been done to your family and to your children, but

49

it will let other Americans know that Congress is listening and

cares and wants to do something.

So, thanks to all of you right here.

Thank you, Chairman.

Mr. MICA [presiding]. Thank you, Mr. Kucinich.

I recognize Mr. Cummings from Maryland.

Mr. CUMMINGS. Thank you very much, Mr. Chairman.

I can only echo what Mr. Kucinich just said. I think that so often

when you think of something like a vaccine, looking at something

that is supposed to make life better and prevent problems, and unfortunately in some instances we have a double-edged sword.

I just have a few questions, Mr. Salamone. Is that how you pronounce your name?

In your testimony, you advocate the creation of a specific method

or formula to calculate lost earnings. Yet some people oppose such

a formula, because it may diminish the awards to successful petitioners. How would you respond to that concern?

Mr. SALAMONE. Well, you know, I have, I think, a very personal

reason for addressing that issue. In the case of my son, he received

zero, no compensation for future lost wages, and I believe in this

case the assumption was if he can walk—which David does like a

drunken sailor, but he gets around with his brace—that he can,

with educated parents, do as well in this life as everyone else.

Well, within a year of his award, David started intermittent

tremors of his arms and hands. And as a result, he now had to do

much of his schoolwork on special equipment. Well, our neurologist

tells us this is directly related to his polio, yet, again, this is something that was after the fact, and therefore—by the way, if I can

use this opportunity, the original legislation provided that if indeed

after a claim was made something like this came up that was directly related to the injury, that one had the option of going back

to the Government and saying, ‘‘This is directly related. We have

this evidence,’’ and the Government would work out an arrangement where they could compensate, if you will, for the needs relating to that additional injury.

Unfortunately, that was pulled back, and the Congress actually

removed that provision, and, as a result, in a case like my son and

others, you have this situation where, again, they are not really

being fully compensated for their injury.

Now, as far as the lost future wages, I believe that this is obviously a complex issue, and the—my concern, candidly, is the fact

that people are totally eliminated from even consideration for future lost wages. So, I think we, first, have to establish the fact that

there should not be a policy with the Government that would allow

a special master to have a policy that says, ‘‘You will not get future

lost wages for your child, because that child can walk or that child

has educated parents.’’ Those are the things that concern me.

Mr. CUMMINGS. There is a great deal of concern that if the

present program is changed, children whose conditions have not

been caused by the vaccines would receive compensation. And how

would you address that concern?

Mr. SALAMONE. I am sorry, sir. Repeat the question.

Mr. CUMMINGS. In other words, there is a concern that if the

present program was changed, children whose conditions have

50

not—have not—been caused by the vaccines would receive compensation.

Mr. SALAMONE. Well, I would first say to you I believe that when

it comes right down to it, the Government should err on the part

of the petitioner, if indeed it is an error. These are very difficult

cases. This is supposed to be a procedure that is less adversarial,

not non-adversarial, and certainly we don’t want to open the doors

completely to cases that are not directly related to vaccine injury.

But I would say if we have cases that even come close to consideration as vaccine-related, that I would rather the Government with

its $1.4 billion trust err on the side of the petitioner.

Mr. CUMMINGS. Well, I certainly would agree with that. Unfortunately, we have many people here in the Congress who probably

wouldn’t. When I look at all of this, having been a trial lawyer for

almost 20 years, to see the results of what happens, for example,

in a malpractice case and see how States have limited the liability

of doctors who may do the wrong thing or may be negligent, it is

interesting.

But when you go through this experience, when you have a problem like this, a vaccine that actually had the opposite effect that

it was supposed to have, I think you get a chance to see that—people get a chance to see that side of it. And I would agree with you,

and I hope that, as Mr. Kucinich said, that we will be able to come

up with some solutions that are fair and that we will do justice to

all of those who may have been harmed.

And I want to thank all of our witnesses for being with us today.

Thank you very much.

Mr. MICA. Thank the gentleman from Maryland.

I would like to also thank all three of our panelists for being with

us and for the testimony you have provided the subcommittee

today. Hopefully, it can help us in doing a better job in revising the

law that was passed to compensate victims, make the structure

and system work that we put in place to compensate for vaccine

injuries.

So, we thank each of you, and we will excuse the witnesses at

this time.

I would like to call our second panelists. Panel two is Dr. Marcel

Kinsbourne, a medical expert with Tufts University; Dr. Arnold

Gale, a medical expert with Stanford University, and Mr. Cliff

Shoemaker, an attorney with Shoemaker & Horn.

As I indicated to our first panelists, this is an investigation and

oversight subcommittee of Congress. We will swear in our witnesses. Also, if you have lengthy statements, they will be made a

part of the record.

Let me see, and is Dr. Gale going to testify too?

Can you raise your right hands?

[Witnesses sworn.]

Mr. MICA. Thank you. All of our witnesses answered in the affirmative.

I would like to welcome each of you and thank you for your participation today. And I think each of you have dealt with this compensation fund and process, and we look forward to your testimony

at this time.

51

First, we will hear from Marcel Kinsbourne with Tufts University.

You are recognized, sir.

STATEMENTS OF MARCEL KINSBOURNE, MEDICAL EXPERT,

TUFTS UNIVERSITY; ARNOLD GALE, MEDICAL EXPERT,

STANFORD UNIVERSITY; AND CLIFF SHOEMAKER, ATTORNEY, SHOEMAKER & HORN

Dr. KINSBOURNE. Thank you, Mr. Chairman, members of the

committee.

My name is Marcel Kinsbourne. I am a pediatric neurologist. I

have held research grants from the NIH. I have served on study

groups of the NIH. I have been involved in the Compensation Program since its inception in 1988; in fact, before its inception, I was

part of a workshop offered for special masters in training for that

purpose. So, I have an overview of the program from its start.

I have also been involved in civil litigation, both for plaintiff and

defense, and so I am in a position to compare the proceedings of

the claims court Vaccine Compensation Act with civil litigation in

this country at this time.

Now, I might just say what everybody else agrees that I am

strongly in favor of public health policies with regard to vaccination. I am addressing specifically the issues nominated by the committee for discussion.

And the first of these, of course, is the question of the adversarial

nature of the proceedings as they now occur. Actually, when the

proceedings first began in the late eighties, I didn’t think they were

that adversarial. I really thought that they were somewhat consistent with the wording of the act which was that they should proceed

‘‘quickly, easily, and with certainty and generosity.’’ This changed, however, and the proceedings have become more

adversarial and continue to become more adversarial, and that

both involves the manner in which the cases are defended, the petitioners are resisted, and the change in the rules that offer a presumption of causation that have already been mentioned by several

speakers today.

These changes all go in one direction. I don’t believe, as I will

explain, that the changes were made based on new science. There

isn’t any relevant new science. The changes are a matter of policy,

in my opinion.

Now, in terms of the manner in which the proceedings are conducted, it is increasingly the case in my experience that the Department of Justice attorneys fight harder and more stubbornly to

resist findings of entitlement. They may use two experts. They may

change experts if the first expert’s opinions didn’t serve the purpose. They may bring in three. A petitioner can’t usually manage

to do that.

In one matter in which I have been involved, the Department of

Justice actually paid a group of independent investigators to perform an original study, an expensive study, to overthrow two

claims for which entitlement had already been found. These are the

cases of Plavin and Hanlon v. HHS.

This kind of funding, this kind of effort isn’t possibly available

to those plaintiff attorneys that still consent to take these cases.

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And I might add that as has been said before, absolutely there is

no way of proceeding in these matters without the help of an attorney; not just an attorney, an attorney who is well versed in the

procedures in the claims court. It has become a highly specialized

aspect of law.

So, not only is it the case that a special master is pressured in

many cases to deny entitlement, it is also the case that when the

special master nonetheless finds entitlement, that the fight goes

on, as you have heard, increasingly at the damages hearings.

Issues that had already been settled in the previous hearing are revived yet again, and then there is the nitpicking that has been described so well by previous witnesses.

Now, not only does this make the process arduous and exhausting, particularly for petitioners, it takes up time. I heard it said at

the last hearing, at which I also testified, that the average time to

settle a claim is 2 years. Well, I don’t know where that figure

comes from. In my opinion, claims that are contested and go

through to entitlement findings take longer. They have taken 4

years, 5 years. The last one that I was involved in had been filed

in 1991. As you have heard, the more time passes, the less compensation is subsequently offered.

Now, if the decision is one that is unwelcome to the Department

of Justice, the Department has the further resource of resorting to

a multi-stage appeals process, and appeals against the decision of

special masters have been increasingly frequent in my experience.

Now, it is also my impression that as part of the more stubborn

contesting of these claims, there has been an increasing effort to

discredit medical experts who assist petitioners by accusing them

of bias against vaccination or in favor of petitioners. In fact in the

same last hearing I mentioned, the Department of Justice attorney

put into the record as an impeachment exhibit the fact of my testimony to this committee last time, and then she argued that the

fact that I testified to this committee showed that I was an advocate, and should impeach my credibility as a medical expert. I have

the transcript with me.

The special masters——

Dr. WELDON. Mr. Chairman, I ask that that transcript be included in the record.

Mr. MICA. Without objection, so ordered.

[The information referred to follows:]

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Dr. KINSBOURNE. In my opinion, the special masters make every

reasonable effort to adhere to the principle of a non-adversarial and

friendly and expeditious process. They used relaxed rules of procedure. They are invariably courteous and compassionate to the

plaintiffs. They try to move the case along, but this gets increasingly hard because of the opposition that is encountered at every

step of the way.

I think that in summary, the quality of the proceedings has approximated to the kind of adversarial argumentation and maneuvering that is typical of civil litigation, and the question is, is that

what Congress wants?

The second topic nominated by the committee was the matter of

criteria for entitlement for compensation. In other words, what are

the criteria by which a claim can be automatically accepted as indicating that the damage complained of was caused by vaccine? Now,

I would like to explain why this is so important.

If it were the case that we had special tests for vaccine injury,

if it were the case that the outcomes of vaccine injury were typical

and that you could look at the chart years later and say, ‘‘Ah, this

must have been a vaccine case,’’ then there wouldn’t be such a

problem. But in child neurology this is the exception rather than

the rule. The reason is that there are a legion of causes of damage

to children’s brains, but the way the children’s brains react to these

damages is quite limited, and the most common outcomes are cerebral palsy, mental retardation, and seizure disorders. And it is usually the case that you cannot tell from the cerebral palsy, from the

seizures, or from the mental retardation what the cause was.

So, in the case of vaccine injury it is like that. If one had to actually prove that the vaccine definitely caused the outcome, that

would be hard and sometimes not a possible job to do, as is the

case also with other causes in child neurology.

One reason why this proof is so difficult is that research is lacking. Now, the research that is lacking is research that could, in

fact, often well have been done by now. In fact, the initial act instructed the Secretary to commission the Institute of Medicine to

prepare reports on the status of the science of vaccine injury causation, and they did so in two reports I think in 1991 and 1994.

In the report in 1994, they made a point of a fact that they had

encountered in their efforts, from chapter 11, ‘‘The lack of adequate

data regarding many of the adverse events of the study was of

major concern to this committee. Obvious needs for research and

surveillance were identified.’’ This opinion of the committee of the

Institute of Medicine was published in 1994. I am not aware that

anything was done about it.

Now, in fact, the rule changes that have been referred to, implemented in 1995 and 1996, were changes that, as everybody knows,

made it harder for petitioners to prevail in their actions. These

changes were not based on new science. There is no new science.

They were not based on the Institute of Medicine recommendation.

Actually, they ran counter to those recommendations.

Here is a specific about that. In the case of DPT vaccination,

which is by far the commonest vaccination complained of, there

really is only one epidemiological study that has been recognized

as being definitive and reliable, and I quote from a publication of

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the Institute of Medicine. The study is called the NCES, National

Childhood Encephalopathy study, which was done in Britain. The

committee says, ‘‘The NCES is the only systematic study of longterm dysfunction after DPT,’’ and the committee endorsed that

study, and the following statement is to be found in the same document: ‘‘The committee concludes that the balance of evidence is

consistent with a causal relation between DPT and the forms of

chronic nervous dysfunction described in the NCES in those children who experienced serious, acute, neurological illness within 7

days after receiving DPT vaccine.’’ So, what are these acute, neurological events? They subdivide

into encephalopathy and seizures. The NCES studied serious seizures lasting more than half an hour or complicated seizures. Well,

what happened after that? Seizures were removed from the table

of entitlement after the IOM accepted the study which incriminated them in relation to DPT.

Encephalopathy. How was encephalopathy defined by the NCES,

which was endorsed by the IOM? I would give a list, if I may, of

the characteristics that were mentioned in the NCES document: altered state of consciousness, confusion, irritability, changes in behavior, screaming attacks, neck stiffness, convulsions, visual, auditory, and speech disturbances, motor and sensory defects. This is

the list the NCES gave, and it is a list that is not inconsistent with

neurological practice.

What is left after the change? One thing: lowered level of consciousness after 24 hours. If you don’t have that, never mind you

have all these other symptoms, you are not on the table, and God

forbid you die before the 24 hours are up, because then, certainly,

you haven’t met the criteria.

So, I wish to present to the committee that the presumption of

causation has been restricted to the point that it is tantamount to

causation-in-fact. It is tantamount to going and proving the case in

court every time over again. So, we have instead this lengthy process, this arduous process which might as well be conducted against

the manufacturers as in the court of claims.

And, now, the Secretary has introduced proposals for legislative

changes. In section three of the proposals, there is a suggestion

which would make it easier for the Government to overthrow even

table injuries. Now, when petitioners have to prove causation-infact because their injuries aren’t on the table, they have to prove

that the pertussis vaccine or other vaccine really caused the problem.

But the Secretary would like to change the burden on the respondent to overthrow a table injury by not having them actually

prove the specific disease but merely argue, ‘‘Oh, there was a genetic cause. There was a metabolic cause.’’ That is in section three.

That section would make it even harder to recover under the terms

of the act.

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Now, with respect to the third point, I have only a brief comment

to make. As has been mentioned several times, there is a large

amount of money in the trust fund. It was contributed not by manufacturers, not by the Government, but by citizens when they purchased vaccines. The purpose was to compensate people who are injured by vaccines. I believe the money should continue to be used

for that purpose.

Thank you, sir.

[The prepared statement of Mr. Kinsbourne follows:]

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Mr. MICA. Thank you for your testimony.

We will now hear from Dr. Arnold Gale with Stanford University.

You are recognized, sir.

Dr. GALE. Thank you, Mr. Chairman, the ranking minority member, Mrs. Mink, and ladies and gentleman of the committee.

Thank you for the privilege of testifying today about the Vaccine

Injury Compensation Program. I am a child neurologist and a

member of the faculty of the Stanford University School of Medicine. And for the past decade, I have participated in the program

by lending my expertise to the review of the medical records of petitioners filing claims for compensation. At the same time, I have

acquired a perspective of the process itself and of the deeper issue

of vaccine-related injury, which I should like to share with you this

morning. Although a wide variety of vaccines are covered by the

program, and while my remarks are pertinent to all of them, I will

focus primarily upon the pertussis vaccine, which has given rise to

the vast majority of claims.

My role as a medical reviewer for the program is little different

than that which I perform in my usual capacity as a clinician.

Keeping in mind the criteria that are set forth in the vaccine injury

table, I review the medical records and the supporting documents

of each claim, seeking to answer these questions: Does a condition

described on the table exist? If so, has it occurred within the prescribed timeframe? And if so, can a factor unrelated to the vaccine

be identified as the probable cause of the condition?

If a condition described in the table occurs within the prescribed

timeframe, and if no factor unrelated to the vaccine can be identified as the probable cause of the injury, then the claim is compensable under the National Childhood Vaccine Injury Act. I file a report with the program to that effect, and the claim typically proceeds to the damages phase of the process.

Alternatively, if no condition described in the table can be identified, or if a condition has its onset beyond the prescribed timeframe, or if a factor unrelated to the vaccine can be identified as

the probable cause of the condition, then the claim is not compensable under the act. I file a report to that effect, and the entitlement phase continues, typically proceeding to an adjudicative hearing before a special master. The process is similar in cases in which

a child may have suffered a significant aggravation of a pre-existing condition following immunization.

Under the act, a table injury without an identifiable factor unrelated to the vaccine is presumed to have been caused by the vaccine, and proof of causation is not required. Only when injuries

occur beyond the timeframe of the table does the petitioner have

the burden of the proof of causation. The fairness of the program

rests heavily, I believe, upon this principle.

The act provides for periodic revision of the table based upon experience and the evolving understanding of the science and the

medicine governing the table. With respect to the pertussis vaccine,

perhaps the most significant of these revisions occurred in March

1995, when ‘‘residual seizure disorder,’’ was eliminated as a distinct condition, and the definition of ‘‘encephalopathy’’ was

changed. The former was undertaken only after careful considerVerDate 11-MAY-2000 09:43 Nov 27, 2000 Jkt 000000 PO 00000 Frm 00066 Fmt 6633 Sfmt 6633 C:\DOCS\66079.TXT HGOVREF1 PsN: HGOVREF1
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ation of the cumulative experience with seizures following immunization.

Most seizures closely following immunization are febrile seizures,

which are typically brief, self-limited events affecting genetically

predisposed infants and children. They are benign and are not associated with untoward outcomes.

Most of the remaining seizures may be triggered by fever in children who have occult epilepsy—that is, an already existing epilepsy—but there is no evidence that the epilepsy itself is caused by

the vaccine, except when accompanied by signs or symptoms of an

acute encephalopathy. Relatively few cases have been affected by

this change in the table.

In contrast to more than 3,600 DTP-related claims adjudicated

under the initial table, fewer than 300 total claims have been filed

since the change in 1995. The definition of ‘‘encephalopathy’’ incorporated into the initial table was vague and confusing to my way

of thinking and to that of my colleagues, and it disregarded the differences in the signs and symptoms that are observed in infants

and older children. Because I had a role in framing the language

of the new definition in 1995, I can attest that the change was motivated solely by a desire to clarify. Only a small fraction of cases

filed since that change has been affected.

If my description of the mechanics of the program, and of its underlying table, is itself a little mechanical and a bit dry, the same

cannot be said of the program’s hearing process. Its adversarial nature is ensured by the participation of lawyers and the special master. What should be a quiet, civil, deliberative discussion of facts

and medicine too frequently degenerates into a contentious, vituperative, decibel-escalating exchange. Ad hominem attacks on physicians by all attorneys are common.

Most disturbing, from my perspective, has been the injection of

pseudo-science provided by self-proclaimed vaccine-ologists. With

accumulated experience, however, the special masters appear better able to readily identify such witnesses, crediting their testimony

with the weight that it deserves.

Each participant in the program—parents, special masters, attorneys, physicians, and others with stakes in the process—possesses

a unique perspective, and it is that perspective which creates perception. Perception is a powerful thing. In 1977, the British Broadcasting Co. televised a documentary warning parents of the potential dangers of the pertussis vaccine. During the ensuing year, the

rate of immunization among infants in Great Britain, a nation with

accessible, free health care, plummeted approximately 45 percent.

During that same period, in a population roughly a quarter that of

the United States, the number of deaths from pertussis, or whooping cough, was quadruple our own. All too quickly, the perception

of risk, which motivated so many parents to withhold immunizations, was replaced by grief.

The parents who petition the program have their own perspectives and perceptions, and they have my empathy and my sympathy for the loss of the children who would have been adults.

Often their children have serious chronic neurologic disabilities,

and they grieve for lost hopes and dreams. Among their needs is

the need to know why. Compensation from the program, then, proVerDate 11-MAY-2000 09:43 Nov 27, 2000 Jkt 000000 PO 00000 Frm 00067 Fmt 6633 Sfmt 6633 C:\DOCS\66079.TXT HGOVREF1 PsN: HGOVREF1
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vides more than the financial resources for future care and the accompanying peace of mind. It vindicates the strongly held belief

that the vaccine is at fault, despite the fact that there is no method

available to determine whether the vaccine did, in fact, injure their

child.

The special masters are dedicated to the principles that guide the

program, the first of which is compassion. Uncompensated claims

are not attributable to their indifference, but rather to the relatively small number of cases that satisfy the minimal requirements of the table. Never is the problem of perception as poignant

as in the instance of the sudden, unexplained death of an infant

following immunization.

In approximately half of such cases, the medical and pathological

records are consistent with Sudden Infant Death Syndrome [SIDS],

a condition not associated with pertussis immunization, according

to the medical literature and the report of the Institute of Medicine. Still, it is unlikely that anything will dissuade a grieving parent that the close temporal relationship between immunization and

an infant’s death is coincidental.

In nearly 25 years as a clinician, I have witnessed a few rare

cases of infants and children whose acute neurologic disorders

began immediately following immunization, and for which no reasonable alternative could be identified. Like most of my colleagues,

I think that such events occur, may be vaccine-related, but that

they are rare.

With respect to the pertussis vaccine, there is no method available today that permits causation in any individual case to be established. This opinion is widely held and well-supported by the

current medical literature. My own decade-long experience with the

program has taught me that literally hundreds, if not thousands,

of youngsters whose parents believe that they have been injured by

vaccines, have, in fact, alternative diagnoses that account for their

neurological disabilities. The rarity of vaccine-related injuries

makes epidemiological studies difficult to design and execute, and

such studies could not establish causation in an individual case nor

prove that such injuries never occur.

A half-century after widespread immunization began, our knowledge of such injuries is sparse. What we do know is that countless

lives have been saved and serious illness and disability prevented

by immunizing against infectious diseases that were once the

scourges of humanity. And, those vaccines have never been safer

than they are today.

Thank you again for the privilege of testifying before you today

on this critical matter.

[The prepared statement of Dr. Gale follows:]

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Mr. MICA. Thank you, and we will hear from our third witness,

Mr. Cliff Shoemaker. He is an attorney with Shoemaker & Horn.

Welcome, and you are recognized, sir.

Mr. SHOEMAKER. Thank you, Mr. Chairman. I am flattered to be

included on a panel with two esteemed doctors. I probably would

be more appropriately placed on the panel with John Euler who is

probably my counterpart in this program.

Mr. Chairman and members of the subcommittee, I am very

pleased to be with you here today to talk to you about a subject

that is very near and dear to me. Before I begin, let me begin by

saying that I would like to place my father’s name, Ralph Shoemaker, in the Congressional Record. My father died on September

11 as I was preparing my testimony for this hearing, and my remembrances of him were constantly with me as I prepared 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 the word ‘‘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

raised a handicapped child and helped her to become a fulfilled,

beautiful person.

The year that I was born, one of my sisters, who was then 9, 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.

And I might add as a sidelight here, Congressman Burton had

an exchange with Mr. Salamone, and it brings up a perfect example of what I am talking about, because I am one of the people who

has said we cannot stop giving polio vaccines until we have vaccinated our population for at least 10 years with kill virus vaccine.

The reason for that is that we do have cases of people who have

contracted polio from live polio vaccine. We know that they can

shed that virus for at least 8 years, so there is a pool of polio virus

there, and you cannot stop giving polio vaccine, at least not the kill

vaccine, until we are absolutely sure that this disease has been

eradicated. So, if there is any doubt about my view on vaccines,

that is it.

In a very real sense, I am here today testifying on behalf of the

United States—excuse me, sir.

Mr. MICA. If I may submit my unanimous consent your request

for also the inclusion of your father’s mention, Ralph Shoemaker,

into the record and also your entire statement. Without objection,

so ordered.

If you would care to go ahead and summarize. Thank you.

Mr. SHOEMAKER. Thank you, sir.

In a very real sense, sir, I am here today testifying on behalf of

the U.S. Government; that is, 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

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prompt justice against itself, in favor of its citizens, as it is to administer the same, between private individuals.’’ I have been involved in vaccine litigation for over 20 years. Prior

to the enactment of the Compensation Act in 1986, the families of

children, as Congressman Waxman explained, were forced to hire

lawyers and file lawsuits against the vaccine manufacturers and

vaccine administrators. These suits were expensive and time-consuming, and the results were quite variable.

At a ‘‘Symposium on Public Concerns of Immunization’’ held at

Georgetown University in 1978, Dr. Leroy Walters made the following statement, which I think is very appropriate for our discussion

today. He said,

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 disabilities.’’

If you don’t mind, I feel very funny just reading into the record

something that I have already written and everyone can read for

themselves. I would like to respond to some of the things that I

have heard here today. I feel like I am ready to explode with so

much information and so much that needs to be talked about.

Congressman Waxman indicated this program was created because plaintiffs only had this alternative to going into court, and

that is true. But as Congressman Burton pointed out, this program

was created because there was a national emergency, and that national emergency was that the vaccine manufacturers were threatening to stop the production of vaccines. This was an emergency,

and Congress dealt with that emergency in a brilliant fashion.

Congress brought together people from all different walks of life.

They brought in the manufacturers; they brought in people from

the Department of Justice, from HSS; they brought in victims; they

brought in groups that represented victims. They took all these

people together, and they forged a political compromise. And I

think it is important to understand that that was a political compromise, not a scientific decision, not a medical decision, it was a

political compromise. The table of injuries that everybody has

talked about today was a political compromise.

Dr. Kinsbourne is right—there was no new evidence that justified changing that table when the Secretary changed the table, and

I hope you will read what I have said about that. The table is

changed now so we have a situation where the only encephalopathy

is one where you have reduced level of consciousness for at least

24 hours. Now, maybe Dr. Gale can explain to me how a vaccine

that is capable of producing that kind of an injury cannot produce

an injury that is less severe? If it can produce a severe injury, it

can produce a less severe one.

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Congressman Burton asked questions about the hepatitis B vaccine. How do you make a study—when you give a baby a hepatitis

B vaccine in the hospital before they leave, how are you going to

conduct the study that Dr. Gale asked about, a study of epidemiology? How are you going to design and implement a study, because

you have nothing to compare that baby with? At 2 and 4 and 6

months, it is hard enough to know what the baby was like and to

show before and after—that is tough enough. But you give it to a

baby and the baby has an injury from the vaccine, how can you

prove it? How do I prove it as a lawyer? That is the perfect way

to disguise an injury from a vaccine. Give it to a baby, and then

you can blame it on genetics or structural abnormalities, and that

is what the Secretary is asking you to do, to not only make changes

to this program but make it more difficult to collect on these cases.

If you agree with their language on genetic abnormalities and

structural lesions, I can guarantee you that there won’t be anybody

on this case.

I just returned from Florida where I visited and met with lawyers who are prepared to work on hepatitis B vaccine claims. We

filed over 130 such claims, and I can tell Congressman Burton that

the problem we have in this program is that our meeting was not

to discuss—well, it was to discuss how we are going to prove causation in these cases—but our meeting was to discuss what we are

going to do when we are forced out of this program if it is not

changed and how we are going to mount civil litigation in these

cases. That is the discussion we were holding.

You are absolutely correct in saying if this program is not fixed,

I can guarantee you that the hawks that are sitting on the sidelines and calling me crazy for staying involved in this program are

going to carry the day, and we are going to be back in court suing

manufacturers, suing doctors, doctors who didn’t recognize that the

first shot caused problems, the second shot caused problems, and

they went ahead and gave the third shot.

One of the things we see of hepatitis B vaccine cases is we see

people who received a series of vaccines and had repeated injuries

after each vaccine to that. We have got to develop methods of showing doctors and telling doctors that if a child has a reaction to one

vaccine, you don’t give him anymore. Stop this dogma of giving it

to a child.

We are working with doctors now who are trying to determine

if there are genetic abnormalities or genetic genomes or genotypes

that can help us to identify children who are high risk of developing reactions to vaccine. That is research that we are doing—plaintiffs’ lawyers, the scourge of the Earth. It is not being done in the

places where it should be done. We need research today, but we

also need a program, and I encourage you when you think of that

military analogy, give us the burden of proof that you use for veterans’ claims. Give us a burden of proof where the benefit of the

doubt truly goes to the petitioner. Take away this idea that this is

a waiver of sovereign immunity and that everything should be narrowly construed against the claimants. That is not the case. This

is a compensation program; it is remedial. The benefit of the doubt

should be in the favor of the claimants in these cases, and if this

program doesn’t start working, something is going to happen.

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I can’t prove causation in a case the way I used to prove in con- tingency litigation. It was not uncommon for me to spend $50,000

on a case to prove causation—hiring experts, performing epidemiological studies, performing biological testing programs. I can’t afford to do that in this program. Today, when I am finally compensated with the meager compensation that I get from this program and the expense reimbursement, I am paying yesterday’s

bills.

That is why none of my compatriots, none of the litigation lawyers in this country are willing to stay involved in this program.

You heard from one of the claimants that her firm is no longer taking any vaccine cases. It is a respectable, well-respected plaintiffs’ firm. Those firms will not get involved in these cases, because they

can’t get paid on time; they can’t get their expenses reimbursed

until the end of the case; they cannot afford to handle these cases.

The war chest that I once carried when I was in contingency litigation is gone. I can no longer afford to do the things that I need

to do. I am embarrassed by the limited amount of things that I can

do to prosecute these cases. And I would say to Congressman Burton, sure I will be happy to represent your grandchildren, but can

you come up with $40,000 or $50,000 to help me do the studies necessary to prove causation in these cases? Because the Government

won’t do it, and there is a reason why they won’t. They feel like

if they show or demonstrate that there is a problem with a vaccine,

then people are going to be afraid, and people are going to not get

the vaccines.

Let me just say—and this is in the conclusion of my presentation—anybody who points to this program and points to the children who are compensated and uses that as evidence that vaccines

are dangerous ought to be ashamed of themselves. And anybody

who points to this program on the other side of the case and says

that the fact that such a small percentage are compensated shows

these vaccines are safe and people are just full of hot air, they

ought to also be ashamed themselves.

That is not the purpose of this program. It is not to try vaccines

and determine whether they are safe. The purpose of this program

is to compensate people in a fair and generous and simple way. If

it is going to be highly adversarial, if we are going to have three

and four experts hired in every case to testify against us, then give

me the resources, give me the money to fight this battle like I

would fight it in civil court.

But I can’t fight these battles the way this program is structured

now. And that is why attorneys like myself are planning for the future, and the planning for the future is if this program isn’t fixed,

then it will not be the model for tort reform that we all want. It

will be a perfect example of how not to reform the tort system.

Thank you.

[The prepared statement of Mr. Shoemaker follows:]

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Dr. WELDON [presiding]. Thank you, Mr. Shoemaker.

We will now proceed with the questioning phase. And the ranking member and the chairman had to step out, so I am going to

continue until they return.

Dr. Kinsbourne, I would like to begin with you. I have to apologize, I was paged out of the room by a phone call, but I was told

that in your testimony you mentioned that after you appeared before the committee the last time, you were testifying in another

case, the objectivity of your testimony was impugned by the Government attorney because of your willingness to testify before the

committee. Is that correct?

Dr. KINSBOURNE. That is exactly what happened.

Dr. WELDON. And what was the name of the attorney who made

that claim?

Dr. KINSBOURNE. Her name is Hewitt.

Dr. WELDON. And what is her position? Is she Department of

Justice?

Dr. KINSBOURNE. Department of Justice, yes.

Dr. WELDON. Could we get a copy of that exchange between you

and her for the record, and I ask unanimous consent that it be included in the record.

What was the nature of her argument? Could you just go over

that?

Let me just explain, the reason I am bringing this up is I am

very disturbed by this. Because if this means that every time we

petition an attorney to provide us with testimony that the Government attorneys who are trying to protect this huge trust fund for

some reason, I don’t understand—it is growing, and yet they keep

trying to protect it—then we are going to have a hard time getting

people to objectively tell us what the problems are in this system.

And I find that testimony you provided extremely disturbing. You

are free to proceed. I am curious to know what was the nature of

the exchange?

Dr. KINSBOURNE. As I said, I do have the transcript, and I will

make it available.

Dr. WELDON. Just summarize it.

Dr. KINSBOURNE. What happened was that in her cross examination of me, she produced my written testimony to the previous committee meeting as an exhibit; had me identify it; had me read passages out of it into the record; did not, in fact, challenge anything

I said; asked me no questions about what I said, but established

that this was my document, this was my testimony.

Dr. WELDON. As I understand it, though, reviewing your personal

background, you have a pretty impressive record of working on

both sides of this issue, correct?

Dr. KINSBOURNE. I have an impressive record—thank you, sir—

of working of both sides of issues; of plaintiff and defense. However, in the claims court, it is not customary for the Department

of Justice to include experts who testified on the other side. So, I

have not, in fact, had the opportunity of testifying for respondent,

although I have expressed my willingness to do so in appropriate

cases.

Now, when it came to closing argument, Ms. Hewitt said to the

judge ‘‘The fact that Dr. Kinsbourne did testify to a congressional

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committee and had criticisms of the process shows that he is to

some extent an advocate,’’ and she compared me unfavorably, in

terms of my credibility as a medical expert, with her medical expert who she felt was not an advocate.

Dr. WELDON. One other question I have for you. You provided in

your testimony some information on a report from the Institute of

Medicine, actually, a fairly old report from the Institute of Medicine—I think it was 1991 or 1992—where they recommended a series of studies that needed to be done to get at some of these issues

of low incidence of very serious side effects regarding vaccines. I

would like to ask that we get a copy of that from you and get that

included in the record. I ask unanimous consent for that.

Mr. MICA [presiding]. Without objection, so ordered.

Dr. WELDON. As I understand it, none of those studies have been

done. Is that correct?

Dr. KINSBOURNE. To my knowledge. The point is not only that

when they asked whether particular vaccines do or do not in principle cause certain outcomes, they have no studies to refer to, and

they were stuck with this and went out of their way to make that

point, and I will provide the information.

Since that time, this problem has become more serious as new

vaccines are being introduced, which almost without exception

would have been classified by them in this way had they been

available at the time. In other words, vaccines about which one

really simply couldn’t say one way or the other whether the relationship existed, not because studies conflict, because studies don’t

exist; have not in fact been done.

The hepatitis B issue that Mr. Shoemaker mentioned is a major

problem in this case. Hepatitis B has been put on the table for a

very rare, almost unknown complication—anaphylaxis. But the impression that many people have that hepatitis B can cause liver

damage, it can cause autoimmune disorders, has not been addressed by systematic scientific study. So, if one is asked, as one

currently is, to proceed on a causation-in-fact basis and one has to

show biological plausibility, one has to show that actually, in fact,

there is evidence that the vaccine did that based on available scientific evidence, there is no such evidence, and the petitioner is out

of luck.

Mr. SHOEMAKER. May I add to what Dr. Kinsbourne just said?

Dr. WELDON. Sure.

Mr. SHOEMAKER. There are studies and then there are studies.

To use the hepatitis B example, we are seeing a lot of cases of postvaccinal encephalomyelitis—that is injury to the nervous system,

the brain, the spinal cord. So, what does the study do? What is the

study that is mounted to look at that? It is a study to see if there

is an increased incidence of multiple sclerosis in hepatitis B vaccine—people who receive the vaccine.

Now, multiple sclerosis is this great big category of injuries. All

it means is multiple lesions in time and space. Post-vaccinal

encephalomyelitis is a very little piece, and actually if it is postvaccinal encephalomyelitis, it shouldn’t even be included in multiple sclerosis, because it has another cause.

So, you look at this great, big universe and study it to try to disprove a relationship between vaccine and post-vaccinal

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encephalomyelitis? If that is the study that is being done, then I

say forget the study, save your money. Don’t spend your money on

a multiple sclerosis study, because there are so many causes of

multiple sclerosis that if you try and look and see if the total universe of multiple sclerosis because of hepatitis B vaccine, you won’t

find it. I can tell you that before you spend the first dollar, and

that is not the type of study that needs to be done.

So, there are studies, and then there are studies, and you have

to do the right kind of study. What we are seeing in those cases,

for instance, is people that have a reaction to the first vaccine in

the series, they start getting better, having some recovery. They

get the second vaccine in the series, and they have a much more

immediate and more pronounced response to the vaccine.

It is what the Government and other doctors refer to as positive

rechallenge. In other words, once could be a coincidence, but twice,

now you see what is happening. You have heard this from one of

the victims who testified today where it wasn’t until after the third

vaccination that they finally said, ‘‘OK, we have got to stop these

vaccines.’’ Dr. WELDON. I would like to ask all three of you to comment on

this one question or concern I have. I am a physician, and this is

my first political job, and the devil is always in the details when

we try to address these problems. And now we have an act, the

Vaccine Compensation Program; it had very good intentions; it has

gone astray, and, frankly, I think the attorneys have led us astray.

Not to impugn you, Mr. Shoemaker or your profession, but it is just

by nature, as Mr. Gale said, you put two attorneys in the room and

it becomes who is going to win. And one side has more funds in

their pocket to fight their battle. I don’t think you can get the attorneys out of the room, frankly. I don’t see how you can do that,

and that is one question I have—could you do this without attorneys? I don’t know if it is possible.

But one of the questions I have is should we have language in

the law that requires that the plaintiffs’ attorneys get compensated

better, because this system is terrible the way it is described where

there are virtually no attorneys willing to practice this type of law

anymore? I believe that is going to need to be addressed.

And, No. 2, do we need to mandate that a certain amount of the

money gets dispersed each year? Because if you are going to have

all these Department of Justice attorneys going to work each day,

and their definition of winning is that no money is given out, and

they have got the deeper pockets to defend their position, then the

ultimate solution may be to mandate that a certain amount of the

money each year be given out and that it not become a case of who

wins and who loses.

I am just looking toward, ultimately, the day when we begin to

draft language that will attempt to try to address the problems

with this program, because I think we are going to have to do that.

It is critically important that we protect the Vaccination Program.

Mr. SHOEMAKER. If I may respond to that. I hope you will read

what I have written about interim fees and costs, because the Government experts, when they testify in these cases, they submit

bills; they are paid within 30 days. I could have brought a stack

of bills here today from doctors that I can’t afford to pay right now.

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It is kind of hard for me as a plaintiffs’ lawyer to go out and beg

some doctor to testify for me in a case when I can’t pay them up

front, and I tell them, ‘‘You may have to wait years to be compensated at the end of this program.’’ I mean, that is me asking

them to testify versus somebody calling them from Health and

Human Services and asking them to testify. That is not quite an

even playing field, and I hope you will read that section about interim fees and costs.

It is important that we be allowed to petition for costs. I just filed 130 hepatitis B claims. The filing fees alone were $16,000. If

it costs me $500 a case to obtain medical records, multiply that by

130, you are looking at $30,000 or $40,000 to collect records. Now,

if I can get an expert at $1,000 apiece to review those claims, that

is $130,000. I am paying yesterday’s bills with the fees that I am

getting today on cases that have been going on for years.

I have remortgaged my house twice. I have taken my kids out

of private school and put them in public school. I have gotten rid

of the boat. I am no longer living the life of a contingent fee lawyer,

and my friends think I am an idiot to stay involved in this program, and maybe I am, but I am dedicated to the program. But if

we are going to have to fight causation battles in these cases, give

us the resources to do it.

And I reject the Government’s proposal to give us interim costs

after an entitlement hearing. That is a token offer, and I reject it.

If you are going to give us interim costs and fees, give it to us at

least several times during the course of a proceeding so we can finance the cases and pay for them.

Dr. WELDON. Dr. Gale, did you have anything you wanted to add

to that?

Dr. GALE. Yes, if I might. There are ways to streamline the process and to make the process less cumbersome, to have the process

take much less time to compensate people. It could be an administrative process. That isn’t what it is now. Now, it clearly is a

litigative process. I don’t have experience in civil court, so I don’t

have a basis for comparison, but I am told that it is a milder experience, but it is still a litigative process.

There would be no need to review records if there weren’t a table

to compare medical records against. And there would be no reason

to have medical opinions if we didn’t have a table. So, clearly, the

table, which is the linchpin of the program means that there will

be a need for physicians on both sides to review records and come

up with professional opinions about what likely happened to this

youngster, when did it happen, and whether or not it was caused

by something other than the vaccine.

That could be eliminated. People could fill out a simple, plain

English form, explain what happened to their youngster, submit a

form, and be compensated. That could happen. I can’t do that, but

the Congress could do that, if that is what it envisions for the program. If it maintains the table, however, then there will be physicians involved. It does not, however, have to be an adversarial

process if there is a bank of physicians reviewing records with the

broadest possible definition of the injuries.

There are three things that can be done to the table, because the

table essentially mandates three things. It describes the injuries

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that are compensable. It describes the timeframe during which the

onset of the injury must occur, and then it describes, I suppose you

could call it, ‘‘an out,’’ and that is, if there is a factor readily identifiable separate from the vaccine that could have caused that injury

in that timeframe, then that becomes a non-compensable case.

For example, you could do away with the provision for factors unrelated; that is, you wouldn’t bother to look for a factor unrelated;

you wouldn’t care. Then a prescribed injury occurring within a certain timeframe, no matter what the child’s medical record or history suggested, would be compensable.

Second, you could expand the timeframe. For example, in pertussis vaccines for encephalopathy it is currently 3 days. You could

make it 7; you could make it 14; you could make it a month or

more. That clearly would expand, not only scientifically, the probability that you would not have permitted any potentially vaccinecaused injuries to fall through the cracks, but necessarily, using

the principle, I suppose, of unanticipated consequence, you would

include an awful lot of youngsters with neurologic diseases that almost certainly couldn’t have been caused by the vaccine. But that

is a decision you could make; you could expand the time window.

And last but not least, you could change, again, the definitions

in the table, if you keep a table, and make them as broad as possible.

Mr. SHOEMAKER. In that regard, making them broad, if you look

at the IOM report that you referred to, there are many conditions

that describe, with reference to various vaccines, where the report

will say specifically this condition—like, let us take brachial neuritis—this condition is biologically plausible. In other words, it is

plausible that the vaccine caused it and that there have been case

reports in the literature reporting this, but there have been no controlled epidemiological studies performed, and therefore their conclusion is that there is not enough evidence to either accept or reject the fact that this was caused by the vaccine.

If those were put in the table, if you included all those things

where it is biological plausible and where there are case reports

and there haven’t been epidemiological studies, you would include

a lot more cases within the table. I like the idea of eliminating the

alternate causes to be able to streamline the table. Sure, you would

overcompensate more than you are now, but so what? Otherwise,

you end up with people on Medicaid; you end up with people with

other programs. I mean, let us open this program up and make it

compensate, make it do some good.

Dr. WELDON. Did you have anything you wanted to add to that,

Dr. Kinsbourne?

Dr. KINSBOURNE. Yes, sir. I think that Dr. Gale’s suggestions are

very humane, and I could certainly not take issue with them. I do

think that the medicine, as I have explained, is particularly technical here, and it is not always obvious to a layperson what is or

what is not a vaccine injury, or even what could be or what could

not be a vaccine injury. I have reviewed many files sent to me, and

many times I am unable to support the claims, because I can tell

that this really wasn’t the vaccine.

So, I think regardless of how one sets one’s criteria, we still need

some legal assistance and some medical consultation, but it could

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be an awful lot less than currently happens. It could absolutely

streamline in the ways that my colleagues have suggested.

Mr. SHOEMAKER. You still need to leave open the possibility of

people that don’t fit a table, even an expanded table. You need to

leave open the possibility of being able to prove causation-in-fact in

those cases, and I would encourage you in those cases to adopt the

standard of proof that is used in veterans’ claims.

If you look at what I have written here on veterans’ claims—and

if I can point to that page very quickly since I didn’t follow my

script here today—it is at the bottom of page 8 and on page 9. I

have put in the specific language that is used in 38 U.S.C. section

5107 for veterans’ claims. And it has the language in it where it

says specifically ‘‘The benefit of the doubt in resolving each such

issue shall be given to the claimant.’’ It is taking it out of the civil

context. If we are not going to be in civil courts and if we are not

going to be litigious, if we are going to make this a program that

is non-litigious, then let us use a standard like this.

I think the military analogy that I referred to at the beginning

about our pediatric warriors, it makes sense to use the same standard of proof that we use in veterans’ claims. So, I would encourage

you to look at that on page 9, and it is specific language; it is being

used somewhere else; it is nothing we have to reinvent; it is language that is there; it has got material behind it; it can easily be

plugged into this statute.

Dr. WELDON. Thank you, Mr. Chairman.

Mr. MICA. Thank you, and thank you for leading a discussion on

the questioning that I think will be helpful as we try to find some

way to fix a well-intended program that has some very distinct

problems.

The only question I might have is if we could take this totally

out of the legal realm. Dr. Kinsbourne, you thought it might have

to be a little of both, but if this could be made strictly an administrative process and then give recourse, if there isn’t satisfaction,

into the legal realm, do you think that might be something that

could be done?

Dr. KINSBOURNE. I think yes, if the potential petitioners had

some guidance counseling from informed people. Some people simply don’t have very clear ideas either way of what is a vaccine injury. As you have heard, often doctors don’t have a clear idea of

what is a vaccine injury; in fact, the information to doctors has

mostly been, ‘‘Oh, vaccine injuries are overstated.’’ That is more

what they are being told than how to recognize them when they

occur. So, somebody with, I think, both medical and legal knowledge should be able to advise them. It doesn’t have to be in legal

proceedings.

Mr. SHOEMAKER. I think given the history—thank you, sir—I

think given the history of the way the Department of Health and

Human Services has administered this program, making it more

restrictive and more difficult and more litigious and more—very

difficult to prove cases—I think if the administrative process takes

lawyers out of it and if claimants don’t have lawyers representing

them, then all I can say is I will be waiting at the other end to

file their civil lawsuits.

Mr. MICA. Dr. Gale, do you want to respond?

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Dr. GALE. I am not sure that I have more to add to that.

Mr. MICA. Well, I think you have pointed out that we could establish some broader parameters for acceptance as possible victims

of vaccine injury, and I think you both have—both Dr. Gale and

Dr. Kinsbourne have pointed out the difficulty in pinpointing the

connection, although you make some assumptions within certain

parameters. I think you said that you could identify those cases

and medically it may be a guesstimate but a pretty accurate assumption. And some that fall outside of those parameters could be

handled through litigation, but for the most part we could probably

expedite many of these cases by going to an administrative procedure.

If we had a panel of medical experts to—if we set the general parameters and made them broad, as you said, Dr. Gale, and then

had a review by a panel of medical personnel, then we went basically to a mandatory arbitration or mediation, do you think that

would work, Dr. Kinsbourne?

Dr. KINSBOURNE. If the panel were given very clear guidelines as

to the criteria that they should adhere to, doctors will—then naturally think the way they do. They will be skeptical; they will be

critical; they will have a high standard for accepting any diagnosis,

and it will be the easiest thing in the world for them to say, ‘‘I am

not convinced,’’ and so on. They would have to be told very specifically at what level of confidence a positive decision needs to be

made. If that were done, I think it would work.

Mr. MICA. Dr. Gale, did you want to respond?

Dr. GALE. I would agree with that. Like Dr. Kinsbourne, I have

reviewed records for the Department of Health and Human Services that seemed immediately, upon review, to fulfill the qualifications in the table and in my opinion were compensable. That is a

very short process. You read the record, make a call later that day,

file a report. That is compensable.

If you keep the concept of a table, that is, if there is a reference

to which injuries or conditions are going to be compensable, which

means that you will not compensate others, and if there is going

to be a time window, which means that somebody will be an

outlier, that is the consequence of that. If the window is at 3 days,

if you are on the 4th day, you will be an outlier. That will change

the nature of how your petition is handled. If you expand the window to 7 days, 8 days will make you an outlier.

So, if you keep those two elements of the table for physicians to

refer to, and then you will have to decide do you or don’t you want

to keep the concept of factors unrelated to the vaccine as part of

the process for physicians to review. That is, if we can clearly identify that a youngster has a tumor that accounts for his or her neurological disorder, do we take that into consideration in deciding

whether a case is compensable or is it sufficient for the disorder

occurring within a time window to simply occur, in which case the

case would be compensable in spite of the tumor or in spite of the

automobile accident?

If you eliminate, as preposterous as this sounds, but it is preposterous examples that usually help us to focus on what we are

doing, a preposterous example would be a youngster who gets an

immunization for school at age 5 or 6 on a Monday and is struck

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by an automobile on Tuesday and goes into a coma and comes to

the hospital and is never well again. If there is no factor unrelated

to the vaccine as part of the reference table; that is, if you have

a condition, encephalopathy, that occurs within 3 days of the administration of the vaccine, and in this case, in my hypothetical,

it would—that would become a compensable case, and that is fine,

if that is what you intend to do. You would need to codify those

guidelines so that if physicians are going to participate in the process, they know what you want of us.

Mr. SHOEMAKER. To expand a little bit on that, I think I would

like to represent the outliers in this case. I will never forget a case

I had where it was determined that the residual seizure disorder

started 75 hours after the vaccination instead of 72 hours after. So,

I would certainly encourage expanding the table, including these

cases that I talked with Dr. Weldon about where there are—where

there is this information that it is biologically plausible, there are

case reports, people suspect there could be relationship, but it

hasn’t been proven or disproven because there have been no epidemiological studies. Get all these things into the table, grossly reduce the alternate cause aspects of the table, and if those two

things are done, I would say, yes, I am all in favor of improving

the table to include more cases, to make it a more inclusive program.

But then the next step is, I think you have to go beyond that for

these other cases, and there are going to still be causation-in-fact

cases out there that don’t fit whatever table you come up with. I

am still encouraging you to look at what I have written about making it clear that this is not a waiver of sovereign immunity, this

is a remedial program; making it clear and changing that burden

of proof to what is used in veterans’ cases, and doing the things

that I have asked in here.

And that brings me really to an issue of the statute of limitations. There are all kinds of statutes of limitation in these cases,

and one of the things I keep thinking about as I puzzle over what

to do with them is why do we have a statute of limitations? This

is a compensation program. Leave the States to take care of the

statutes of limitation as to whether people can file civil lawsuits.

That is their job; let them do it. This program won’t affect it.

I suppose as long as you are in the program, it will toll the State

statute of limitation. That is fine; I agree with that. But why do

we even have a statute of limitations in this? I get calls all the

time. I get calls from people who were vaccinated August 5, 1997,

with hepatitis B vaccine. They had to file their claim by August 6,

1999, whereas somebody vaccinated 2 days later had until August

7, 2000. Now, that doesn’t make any sense. The only purpose of

that is to get lawyers in trouble and have them call their malpractice carrier because they screwed up. It doesn’t make any sense

at all.

I applaud the Department of Justice for asking for a 6-year statute, but why have any statutes of limitation at all? I am getting

calls from people—now, in the literature, it is coming out about

whether or not MMR vaccine causes autism. Well, eventually that

may be proven, and if it is proven, what about all those old cases

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that had autistic children from MMR vaccine? Are they out of luck

or can they file the claim?

You are going to have all kinds of problems—if you change the

statute of limitation to 6 years, what do I tell the person who was

dismissed 2 years ago because he came to me 3 years and 6 days

after the statute of limitation, and his child’s seizures had started

3 days after the vaccination? So, when he walked into my office the

first time it was too late. I filed the claim; I got dismissed, because

it was too late. I was bound to 3 years.

Now, if you add 6 years soon enough, I should be able to refile

his claim I hope. But what if you don’t get it added until it is more

than 6 years since the vaccine? Now, I can’t file his claim, but I

can still go into civil court and sue, because it is a child, and in

most States, the statute of limitations is tolled during minority. It

makes no sense.

Anybody that thinks this an easy program to work in as a lawyer—I can guarantee you there are plenty of pitfalls in this program, and we all are looking over our shoulder every day because

of the myriad of problems that we have like this. And I could go

on and on and talk about them, but why even have a statue of limitations?

Mr. MICA. Mr. Burton.

Mr. BURTON. Let me just say, Mr. Shoemaker, and I apologize,

I just walked in, but if you could send the chairman of the subcommittee and myself a list of things that you think could or

should be done to eliminate these inequities, we will see if we can’t

work on it together—— Mr. SHOEMAKER. Thank you, sir.

Mr. BURTON [continuing]. Mr. Mica and myself, to get them corrected.

Mr. SHOEMAKER. Thank you, sir.

Mr. MICA. I would like to thank each of the panelists on our second panel for their insight and for their recommendations. We are

going to try our best to see how we can reform this Vaccine Injury

Compensation Program that was set up with good intent but has

gone astray here.

We particularly appreciate Dr. Kinsbourne and your besmirched

reputation having dealt with our committee. We hope that you recover, but professionally we admire you and thank you again for

offering your testimony. Once again, sometimes people come back

for a second dose of abuse.

Mr. Chairman.

Mr. BURTON. Yes, I am sorry I missed your testimony, Dr.

Kinsbourne. My assistant just told me how you were discriminated

against, I guess you would say, because you testified before our

committee. We will be back in touch with you and talk to you about

that as well. Thank you, sir.

Dr. KINSBOURNE. Thank you, sir.

Mr. MICA. Thank you. We will dismiss this panel and call our

third panel.

Our third panel consists of two witnesses, Mr. Thomas E.

Balbier, Jr. He is the Director of the National Vaccine Injury Compensation Program with the Department of Health and Human

Services. The second witness is Mr. John L. Euler, and he is the

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Deputy Director of the Torts Branch, Civil Division of the Department of Justice.

Gentleman, if you will stand and be sworn.

[Witnesses sworn.]

Mr. MICA. The witnesses answered in the affirmative.

As I said, if you have any lengthy statements or documentation

you would like to be made part of the record, on unanimous consent request, that will be done.

First, we will recognize the Director of the National Vaccine Injury Compensation Program, Mr. Thomas E. Balbier, Jr.

You are welcome, sir, and recognized.

STATEMENTS OF THOMAS E. BALBIER, JR., DIRECTOR, NATIONAL VACCINE INJURY COMPENSATION PROGRAM, DEPARTMENT OF HEALTH AND HUMAN SERVICES; JOHN L.

EULER, DEPUTY DIRECTOR, TORTS BRANCH, CIVIL DIVISION, DEPARTMENT OF JUSTICE

Mr. BALBIER. Good afternoon, Mr. Chairman and members of the

committee. I am pleased to be here this morning to talk to you

about the National Vaccine Injury Compensation Program. With

me to provide additional information if needed, are Dr. Geoffrey

Evans, the Medical Director for the program, and Mr. David Benor

from our Office of the General Counsel.

The National Vaccine Injury Compensation Program has been

hailed by Secretary Shalala as the cornerstone of our Nation’s successful childhood immunization program. It provides a unique service to families suffering through one of the most difficult experiences imaginable. It makes a system available through which families can receive financial help in the most efficient and fair manner

possible, while still preserving their rights to file suit in the tort

system.

The program significantly reduces, but it cannot eliminate, the

tension and adversity inherent within any litigation process. As

with every Federal benefit program, there are going to be eligibility

requirements which seem unfair to some applicants. I can assure

you that everyone involved in the administration of the program

makes a concerted effort to ensure that fairness is the operating

principle in dealing with every family filing a claim under the program.

We have been listening to concerns raised by those who may feel

the system has been unfair and more adversarial than they had expected. It is critical to remember that although the program is far

less adversarial than the tort system, it does encourage anyone

who believes they have a condition caused or aggravated by a childhood vaccine to file a petition for compensation. Petitioners’ rights

are vigorously defended and advocated by their attorneys, who are

paid regardless of whether petitioners are compensated. However,

it was never intended to serve as a compensation source for a wide

range of naturally occurring illnesses or conditions, which unfortunately affect many of our children.

The process of determining whether, and at what level, compensation should be awarded will always involve conflicting opinions and a natural tension. This has been recognized by everyone

involved in the day-to-day administration of the program as well as

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by the Advisory Commission on Childhood Vaccines [ACCV], which

was established by the act to ‘‘advise the Secretary—of HHS—on

the implementation of the program.’’ The members of the ACCV include parents of children injured by

vaccines, their attorneys, representatives of vaccine companies, and

recognized medical experts in childhood diseases. This diverse body

has provided constant oversight of the operation of the program,

advised the Secretary on each and every modification of the vaccine

injury table, and has made numerous legislative and administrative recommendations over the years aimed at improving the operation of the program.

Most recently, it developed and approved a series of recommendations that form the basis for legislation recently proposed

by the Secretary of HHS. These proposals include many enhancements aimed at making the program more streamlined and less adversarial for its intended beneficiaries. The proposals would double

the statutory time limit for filing a claim, expand compensation to

families, and simplify the process for adjudicating claims.

I would like to talk for a minute about concerns related to the

Vaccine Injury Compensation Trust Fund. The trust fund was established to ensure that a constant source of funding would be

available for the payment of compensation under the program. The

trust fund is financed by an excise tax of 75 cents per dose imposed

on each vaccine covered under the program. At this time, the trust

fund balance is in excess of $1.4 billion. During fiscal year 1998,

the trust fund received total income of $183 million, with $116 million coming from excise tax revenue. The remaining $67 million

came from interest on the balances in the trust fund and more

than covered the 1999 outlays for awards, and for attorney fees and

costs, of just less than $50 million.

The trust fund should be viewed as a specialized public health

insurance fund, maintained with adequate reserves to handle liability exposure as new childhood vaccines come to the market and

as important ongoing surveillance activities of the Public Health

Service spawn new scientific studies of theoretical vaccine-related

adverse events.

Recently, coverage under the program was expanded to include

four additional vaccines for which 279 petitions have been filed. In

addition, there are more than 300 vaccines in various phases of research and development, some of which may eventually be added

for coverage under the program and result in increased liability.

There is good reason for the public to have confidence in the

overall operation of the program. There have been two comprehensive, independent program evaluations conducted since the program was first enacted. The first, conducted by the HHS Office of

Inspector General in 1992, concluded, ‘‘The case process is efficient;

the program is well organized with good procedures; no unnecessary duplication of effort exists; roles and responsibilities are clearly defined; coordination and communication among the Federal

agencies is strong, and petitioners and their attorneys are generally satisfied with their experience in the program.’’

The second study was done just last year when the Federal Judicial Center completed a report on the program, which concluded, in

part, that ‘‘the case-management innovations and handling of exVerDate 11-MAY-2000 09:43 Nov 27, 2000 Jkt 000000 PO 00000 Frm 00107 Fmt 6633 Sfmt 6633 C:\DOCS\66079.TXT HGOVREF1 PsN: HGOVREF1
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pert testimony function well in the VICP.’’ Currently, the General

Accounting Office is conducting a review of the program at the request of Senator Jeffords, and the GAO has indicated that the results of the review should be released by the end of this year.

All indications are that this program is working very much as intended by Congress. There will always be program areas that can

be improved, and we continue to implement initiatives to address

these areas. The program has always been open to advice from all

interested parties, and mechanisms are in place to assure that the

varied interests of families, health care professionals, attorneys,

and the vaccine industry are represented at a regular public forum.

The ACCV, with its widely diverse membership, brings a good

balance of perspective and has been instrumental in identifying

program improvements that have consensus support. With strong

ACCV support for the administration’s proposed legislative agenda

to make this innovative program even better, it is now up to Congress to move these important changes forward as quickly as possible so that our children can reap the benefits of the program ‘‘in

the most efficient and fair manner possible.’’ Thank you once again for allowing me to come here today to tell

you about the National Vaccine Injury Compensation Program. I

will be pleased to answer any additional questions which you may

have.

[The prepared statement of Mr. Balbier, Jr., follows:]

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Mr. MICA. Thank you, and we will suspend questions until we

have heard from our other panelist.

Mr. John L. Euler, Deputy Director of the Torts Branch, Civil Division, Department of Justice, you are recognized.

Mr. EULER. Thank you, Mr. Chairman and members of the subcommittee. I appreciate the opportunity to appear before you today.

So that I may limit my remarks, I request that my full written

statement be entered into the record.

Mr. MICA. Without objection, so ordered.

Mr. EULER. Thank you, sir.

Congress in the 1980’s was faced with a looming public health

crisis concerning immunizations which involved complex, hotly debated medical issues overlaid with the emotion of personal loss and

tragedy in individual cases. In order both to provide a more feasible avenue of compensation and stabilize the national immunization policy, Congress established this program.

Petitioners are afforded a less adversarial system with free counsel in which their meaningful participation is assured. The debate,

the emotion, the complexity of the cases were not eliminated and

never will be, but an effective mechanism is in place. As a result,

almost 5,000 cases have been resolved and numerous families compensated while the supply of life-saving vaccines has been assured.

The act of 1986 created a much needed alternative to products

liability and medical malpractice litigation for vaccine injuries. It

removes many of the more difficult elements of proof that plaintiffs

faced in traditional civil court. The program is no-fault. In other

words, claimants need not establish that the vaccine was defective

or that the doctor was negligent. The process itself is characterized

by streamlining features. Neither the rules of evidence or procedure apply rendering virtually all evidence that petitioners seek to

present admissible. The special masters make every effort to allow

the parties to present their best case.

By design, this is not a straight claims process nor traditional

litigation but rather a hybrid system that blends the best of both,

even if it cannot escape entirely the frustrations inherent in any

adjudication. Critical to the prompt resolution of cases is the completeness of the petition. This is a front-loaded system. In other

words, petitioners are responsible for identifying the specific nature

of their claim and providing all medical records and related documents. When the initial filing is incomplete, petitioners are granted

liberal extensions. If there is delay, it is most often because of an

incomplete record or an underdeveloped medical position. The pace

of the process is largely controlled by petitioners.

The role of the Justice Department is to implement the statute

and uphold the provisions of the act. In other words, we help ensure that compensation is provided to those who meet the criteria

determined by Congress. We are obliged to protect the trust fund

against claims by those who have not suffered a vaccine-related injury.

In the spirit of the act, we do this in a far less adversarial manner than defendants in civil litigation. We participate in an early

telephonic conference with petitioners and the court to discuss the

deficiencies in the petition. The format of the hearings is informal

and accommodating. The hearings are undertaken with a sensitivVerDate 11-MAY-2000 09:43 Nov 27, 2000 Jkt 000000 PO 00000 Frm 00117 Fmt 6633 Sfmt 6633 C:\DOCS\66079.TXT HGOVREF1 PsN: HGOVREF1
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ity to the fact that these cases involve highly emotional and personal issues often concerning severely injured children.

With regard to determining compensation, Congress has set forth

a detailed list of compensable items. While it is often time-consuming, the key is that the program process is far more thoughtful and

tailored than other systems. In most vaccine cases, the goal is no

less than establishing a custom tailored plan of life time medical

care, frequently a cooperative effort. I estimate that 90 percent of

the damages cases are settled without a hearing.

The Department published a packet entitled, ‘‘Steps to Streamlining Damages Under the Program,’’ which sets forth ways to expedite the damages phase. We distribute this document to counsel,

and I have copies of it with me today. We also issued a guide to

assist petitioners’ attorneys with attorneys’ fees and costs, and I

have copies of that as well.

In spite of these numerous accommodations, resolution of these

cases simply cannot always be accomplished quickly. There exists

an obvious tension between efficiency and due process. The issues

can be difficult and complex. The amount sought is frequently in

excess of several million dollars.

In short, I believe the program is working as designed. As with

any Government program, with specific criteria, there will be applicants who are dissatisfied, even among those who are awarded

compensation. Yet we cannot ignore the statutory criteria or the

consensus of the scientific community on medical causation issues.

It is a program that relies heavily upon the most current and accurate scientific evidence available—it does in fact rely on the most

current and accurate scientific evidence available.

In resolving claims, the court, consistent with statutory guidelines, does not require scientific certainty, simply a preponderance

of the evidence.

Mr. Chairman, thank you again for this opportunity. I will be

pleased to answer any of your questions.

[The prepared statement of Mr. Euler follows:]

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Mr. MICA. Thank you, and I would like to yield now to the chairman of the full committee for questions.

Mr. BURTON. Mr. Euler, I understand your employee, Ms. Hewitt,

was the one who challenged the credibility of Dr. Kinsbourne when

he testified recently at a case. Can you tell me why that happened?

Mr. EULER. According to Dr. Kinsbourne, Mr. Chairman, Ms.

Hewitt entered into the record the fact that Dr. Kinsbourne had

testified.

Mr. BURTON. What does that have to do with anything?

Mr. EULER. Well, it has to do with cross examination. Normally,

in cross examination, previous testimony of a witness, things that

have been published, things that they have said have been used.

Certainly, petitioner’s counsel will use things that experts have

said in an effort to cross examine.

Mr. BURTON. So, it was assumed that he had a bias, because he

testified before our committee and what he said?

Mr. EULER. I have not seen the record. I understand from Dr.

Kinsbourne that she argued bias. Now, this is a pending case——

Mr. BURTON. Yes.

Mr. EULER [continuing]. And I hesitate to talk about a pending

case.

Mr. BURTON. Ms. Hewitt works for you, doesn’t she?

Mr. EULER. Yes, she does.

Mr. BURTON. Here is what she said: ‘‘The fact that he recently

testified before Congress about a number of issues, but in particular about his views on the problems with this program, I think also

shows that to some degree he is an advocate on behalf of the petitioners, and Dr. Holmes is not.’’

I didn’t know that testifying before Congress impeded people’s

ability to testify in courts of law.

Mr. EULER. Well, I——

Mr. BURTON. I think you ought to talk to Ms. Hewlitt—Hewitt,

or whatever her name is. I mean, it seems to me, you don’t know

everything that she said, and she is your employee, isn’t she?

Mr. EULER. That is correct.

Mr. BURTON. And you haven’t talked to her about this?

Mr. EULER. I have not. But I appreciate—and I think that point

that Dr. Weldon made is a good one. I think he raised the point

that this might chill expert testimony. And in that respect, I think

we are duly rebuked. I don’t think we should be——

Mr. BURTON. Well, we have had problems like this with the Justice Department before.

There have been 6,000 cases filed, 3,500 dismissed, 1,400 settled,

and 1,100 pending according to the records we have. This is supposed to be a non-adversarial process, and yet when you were testifying, Mr. Balbier, you said it is less adversarial. It is supposed to

be non-adversarial, isn’t it?

Mr. BALBIER. That is not my understanding of the statute at all.

Mr. BURTON. Well, Mr. Waxman who wrote the law said it was.

Mr. BALBIER. I heard Mr. Waxman say that the program is supposed to be less adversarial than the tort system. If it truly were

a non-adversarial system——

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Mr. BURTON. I guess we could go back and read the record earlier today, but I was sitting here, and I am pretty sure he said nonadversarial. But, anyhow, let us not dwell on that.

Mr. BALBIER. I would think that if it truly were a non-adversarial system, you would not have advocates representing the families

that are affected by childhood vaccines.

Mr. BURTON. The reason you have advocates appearing on behalf

of these people is because their kids have been harmed, and they

are not getting proper treatment by the Federal Government, and

because of that, they have to hire attorneys.

You know, my two grandkids, we have tried to find attorneys. Do

you know how hard it is to find an attorney to take one of these

cases because of the way you guys run them around? They don’t

want to do it. They don’t want to take 2, 3, or 4 years, because they

know you can’t afford to pay it.

You know, you said that among those that participate in setting

the standards in the decisionmaking process were the vaccine-producing companies. Is that correct?

Mr. BALBIER. That is correct.

Mr. BURTON. Why?

Mr. BALBIER. The statute requires, or sets out who serves on the

Advisory Commission of Childhood Vaccines.

Mr. BURTON. And the vaccine companies are required to sit on

that board to make—— Mr. BALBIER. Yes, they are, sir.

Mr. BURTON. Well, I think that is something that should be

looked into.

Why should those who have a vested interest be involved in the

decisionmaking process. The reason this system was set up in the

first place was because the pharmaceutical companies said that

they were in jeopardy of having severe lawsuits that could jeopardize the viability of the companies.

And so what Congress said was, ‘‘OK, we are going to try to help

you out by coming up with a non-adversarial situation, procedure,

where you won’t be jeopardized, but money will be put into a fund

for each shot that is given to protect the people who might be

harmed.’’

And, so it has become adversarial, and they are involved in the

decisionmaking process. That makes no sense. It just doesn’t make

any sense to me. They should not be involved. You should have

medical professionals and scientists who understand, like Dr. Kennedy who appeared before this committee, who said that 50 percent

of the DPT shots—50 percent of those who got the DPT shot had

adverse effects. He said 50 percent, and he is a scientist that has

been working on this at the University of Oklahoma.

And yet the people who make the DPT shots can be involved in

the decisionmaking process when we are talking about settlements.

I don’t understand that. And the DPT shots are still being given

even though we have known for years that they have 50 percent

side effects; some severe, some not so severe.

I mean, these pharmaceutical companies make major investments in vaccines; I understand that. And they have a very strong

financial interest. And if something goes wrong with these vaccines

and they are taken off of the market, they suffer severe losses.

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And, so I can understand why they want to keep those on the market and why some people maybe—maybe—at HHS and FDA protecting and allowing them to give things that are dangerous to people these vaccines, these kids.

And, so for them to be involved in any way in the decisionmaking

process doesn’t make any sense to me, because they do have a vested interest.

Mr. BALBIER. I would agree with that. They are not involved in

the decisionmaking process, sir. They are represented on the Advisory Commission, which is strictly advisory. They do not make any

decisions through the adjudicative process, but they do make recommendations to the Secretary.

Mr. BURTON. I am sure they do.

Mr. BALBIER. And there is one person representing vaccine companies.

Mr. BURTON. Yes, I know.

Mr. BALBIER. We also have petitioners, attorneys; we have two

parents who sit on that—— Mr. BURTON. You know, Shakespeare said, ‘‘A rose by any other

name would smell as sweet.’’ If they are involved in the process at

all because they have a vested interest, it is a mistake, especially

those who have a lot of money invested in vaccines that are questionable.

We heard just a little while ago—and I am sorry if I am going

too long, Mr. Chairman—we heard just a little while ago about a

fellow whose child suffered from polio, because they gave him live

vaccine, and they have known for decades that there was that risk,

while at the same time, for decades, they have dead virus vaccines

that could be given to people that were not nearly as risky.

Why was that live vaccine kept on the market all those decades?

Why is the DPT shot being used today when we had people testify

here before the full committee that it was a problem, a danger?

And then on the Advisory Committee you have the pharmaceutical

companies. I think it is something we need to take a hard look at.

One-quarter of the claims have been adjudicated and finalized—

one-quarter. So, we have 3,500 people who thought they had a legitimate case in a non-adversarial system. Their case was dismissed—I don’t know what happened to them—1,100 are pending,

and out of 6,000 only 1,400 have been settled.

I just don’t understand that. Are the decisions made by this

board objective or subjective?

Mr. BALBIER. I would say that the recommendations made by our

Advisory Commission are as objective as they can be, and in fact

whenever anybody who serves on that commission does have a

vested interest on any matter that is being voted upon, they recuse

themselves from a vote on that matter, which has happened frequently, especially with the vaccine companies’ representatives. For

any issue that involves the vaccine made by the company that they

represent, they do not vote on that issue; they never have.

Mr. BURTON. OK, we have—my staff just told me they have 24

people on one of the decisionmaking bodies, and 11 of those have

received money from the pharmaceutical companies that were

being investigated. That is almost half. You say they all recuse

themselves?

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Mr. BALBIER. No, that is a different advisory committee, I believe. I believe the staff perhaps is referring to the Advisory Committee on Immunization Practices, which makes recommendations

on immunization policy; that is, which vaccines are given and

when, to children.

Mr. BURTON. It says it is an FDA advisory committee, Vaccines

and Related Biological Products Advisory Committee, Center for

Biologic Evaluation and Research.

Mr. BALBIER. That is yet again another advisory committee involved in immunization, which makes recommendations to the

Food and Drug Administration for licensing.

Mr. BURTON. Can you give me the makeup of the committee we

are talking about?

Mr. BALBIER. Yes, I can. The Advisory Commission—— Mr. BURTON. How many of those people are physicians or scientists?

Mr. BALBIER. I’ll be happy to answer. The Advisory Commission

on Childhood Vaccines, by design of Congress, is a very diverse

group. Its purpose is to make recommendations to the Secretary on

the operation of the Compensation Program. It is comprised of nine

voting members—three doctors, three lawyers, and three members

of the general public.

Mr. BURTON. OK, now the three doctors, where do they come

from?

Mr. BALBIER. Two of them have to be pediatricians; one does not.

Mr. BURTON. Do they have anything to do with HHS or FDA or

any of the Government agencies?

Mr. BALBIER. That is a tough question to answer. By their very

service on the commission—— Mr. BURTON. I don’t know if it is very tough or not. Do they have

anything to do with FDA, HHS, or any governmental agency?

Mr. BALBIER. Many of the members on our commission have

served on other advisory committees, for example. The current

members in the medical community—Dr. Sam Katz has served

on——

Mr. BURTON. How are they compensated?

Mr. BALBIER. They are compensated for their actual service that

day on the Advisory Committee at a rate of compensation that is

set in the statute.

Mr. BURTON. Do any of them serve on any advisory boards or any

pharmaceutical advisory boards connected with the pharmaceutical

industry?

Mr. BALBIER. If they do, they have to indicate that to us.

Mr. BURTON. Well, I would like to have, for the record, the backgrounds, the biographical sketches, and their connections for all

three of those people, if it is possible.

Mr. BALBIER. OK.

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Mr. BURTON. Then you have three lawyers. Do the lawyers represent any agencies of the Federal Government in addition to serving on these boards?

Mr. BALBIER. No. The statute requires that one of the lawyers

has to be a petitioners’ lawyer, somebody who represents petitioners under the compensation program. One has to be a lawyer who

represents a vaccine company, and then—— Mr. BURTON. One of them has to be a lawyer that represents a

vaccine company.

Mr. BALBIER. That is in the statute.

Mr. BURTON. Why?

Mr. BALBIER. Because it is in the statue.

Mr. BURTON. That seems, again, like a possible conflict of interest, because they represent a vaccine company who has a vested interest in what is paid and what isn’t paid and where they are sued.

I think we need to look at that.

I would like to know who that lawyer is and what companies he

represents.

Mr. BALBIER. OK.

Mr. BURTON. OK?

Mr. BALBIER. His name is Paul Strain.

Mr. BURTON. Well, I don’t want it right now.

Mr. BALBIER. We can provide that for you.

Mr. BURTON. I want to have the complete background—what

companies he represents, what his background is, and whether or

not any of the vaccines that are under investigation as far as compensation being paid to patients.

Mr. BALBIER. Right.

Mr. BURTON. And if he has represented in the past or currently

any of those companies—in the past or currently.

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Mr. BURTON. OK, now what about the third lawyer?

Mr. BALBIER. The third lawyer doesn’t have to be of any specified

affiliation.

Mr. BURTON. Could he be one that worked for a pharmaceutical

company?

Mr. BALBIER. No, in my view, that would exclude him from being

eligible.

Mr. BURTON. Well, I want to check on that too. I want the same

on his as well. And, also the lawyer that represents the families,

I want to find out if any of those lawyers had any connection whatsoever with any pharmaceutical companies in the past.

I would like to have that in detail, and if I don’t get it, we will

subpoena them. I am prepared to subpoena them, so you be sure

to tell me that.

Now, what about the three civilians?

Mr. BALBIER. There are three members of the general public.

Within that category——

Mr. BURTON. Do any of those have any connections with pharmaceutical companies?

Mr. BALBIER. I can’t answer that question.

Mr. BURTON. Well, I want that too. I want to know if anybody

that serves on this advisory panel—any of them—have any connection to pharmaceutical companies, have ever received any moneys

from pharmaceutical companies, represented them in any way, and

we are prepared to send subpoenas to any of them if we don’t get

complete backgrounds on them. OK?

I think I have talked long enough, Mr. Chairman.

Mr. MICA. Thank you, Mr. Chairman.

I have some questions, first, for Mr. Balbier. You have resolved

1,400 cases in which there has been compensation. Is that correct?

Mr. BALBIER. That sounds about right.

Mr. MICA. And over what period of time?

Mr. BALBIER. That is over the entire history of the program since

it was first created.

Mr. MICA. Is that 1988, was it, or 1987? Are we talking about

140 cases a year?

Mr. BALBIER. There are about 100 or so claims filed, on average,

each year, but the vast majority of claims filed were for years prior

to the creation of the program. There was no statute of limitations.

Mr. MICA. Right now, there are about 100 cases filed per year?

Mr. BALBIER. Roughly. This year is an exception, of course,

because——

Mr. MICA. Tell me about your budget.

Mr. BALBIER. Sure.

Mr. MICA. And you said this year you awarded how much in compensation?

Mr. BALBIER. So far this fiscal year, we have paid out $47.7 million for the——

Mr. MICA. That would be just through to August?

Mr. BALBIER. That would be through the end of August, and that

is just for the pre-1988 program.

Mr. MICA. Your last complete year of awards, how much was

that? That would be 1998?

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Mr. BALBIER. A total of $135 million divided between the pre1988 program and the post-1988 program—$79 million for the pre- 1988 program and $56 million for the post-1988 program.

Mr. MICA. How big is your staff?

Mr. BALBIER. My staff is about 21 employees.

Mr. MICA. Twenty-one employees. Full-time. And your expenses

in the last fiscal year that you have a complete record for, I guess

that would be 1998?

Mr. BALBIER. That would be $3 million, and that includes not

only the funding for our staff but also funding for all the expert

witness testimony that is provided to the court as well.

Mr. MICA. So, $3 million and hundred and some million in

awards—$135 million?

Mr. BALBIER. Yes, sir.

Mr. MICA. Have there been any dramatic changes in the size of

staff or expenditures for administrative costs of late, the last couple

of years?

Mr. BALBIER. No, sir. It has been $3 million since 1994.

Mr. MICA. Pretty much steady? How many of your staff are dedicated to analyzing the caseloads and outcomes?

Mr. BALBIER. We have physicians that work for the staff, and

currently we have three full-time physicians on staff right now who

review claims.

Mr. MICA. Are you seeking to add staff in the near future or do

you have staffing requirements?

Mr. BALBIER. No, we are not seeking to add new staff.

Mr. MICA. And how do you determine the amount the medical reviewers are paid?

Mr. BALBIER. It is really set by the standards used Governmentwide for physicians.

Mr. MICA. There has been—there was testimony earlier about

the change in table eligibility as the result of changes in table.

What is the difference in caseload before and after—was it 1994 or

1995—1995, March 1995 table changes? Was there a substantial

change in the number of cases before and after?

Mr. BALBIER. There really isn’t; no, sir. The number of claims

filed in fiscal year 1994, which was the year before the table

change—— Mr. MICA. And how many was there?

Mr. BALBIER [continuing]. Was 106. The number of claims filed

during 1995 did increase to 179, and 75 of those claims were claims

that were filed for the period of time between when we published

the final rule amending the table and the 30 days later when it

went into effect. So, we received a number of claims that were filed

clearly to get within the guidelines under the original table. And,

so the claims went down the following year to 84 and then picked

back up to a level of 103 the year after.

Mr. MICA. Now, you cited a couple of reviews of this whole process that have been done, and I guess there is one ongoing. I guess

the Senate has requested a review also. And you say for the most

part most folks who have had to deal with the fund are satisfied.

You heard dissatisfaction about the length of time, particularly one

case that was brought to our attention—the Mulhauser case—

which took some 6 plus years.

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I think that you are one of the two witnesses that testified that

some of the delay was due to the victim as opposed to the Department. How do you respond to the charges from the victim that the

delay is due to the Department?

Mr. BALBIER. One of the difficulties I think that we have in the

damages process, which as I understood her testimony, the part of

the process that she said took a rather lengthy time, is that from

the petitioner’s standpoint and from their attorneys who represent

them, their job is to get as much money for their client as they possibly can.

On the Government side, we have a different task. Our task is

not to limit compensation to pay out as little as possible. Under

normal litigation, that would be the role of anybody who is sued

in any sort of a lawsuit, but that is not our role. Instead, our role

is to try to provide a reasonable level of care for the vaccine-related

injuries.

I think that is perhaps the reason for the problem. Not only do

we have to develop a life care plan that meets the requirement of

the statute, and that provides for all the various elements of compensation in the statute, but we also have to try to figure out

which items of care are related to the vaccine injury and only pay

for those injuries.

Mr. MICA. Well, it sounds like a lot of—there was a great deal

of dispute, at least in this case, about small ticket items as opposed

to the larger picture and also giving sort of benefit of the doubt to

the petitioner.

Is there any way that we can speed this process up or make it

less contentious and adversarial?

Mr. BALBIER. There is. We have been looking at this, and our Advisory Commission has been looking at this issue to try to speed

up the whole process.

Mr. MICA. Does that mean a statutory change?

Mr. BALBIER. Yes, it does, although we have done a number of

things administratively to try to speed up the process as much as

we can.

However, I think to view the litigative process—and it is a

litigative process—with only an eye toward speeding up the process, could create some problems that we may not want to create.

In other words, we could have a speedy process, but then people’s

rights would not be protected.

Another difficulty, quite frankly, is the time it takes to negotiate

damages on a claim—and that is done by the Department of Justice trial attorneys—they have to develop a life care plan that will

meet the needs of that child for the rest of their life. Oftentimes

it is in the interest of the petitioner to delay that so that they can

see how the child develops. That is done as part of their strategy.

So, yes, we could make a quicker process, and there are many

ways that you heard earlier individuals testify that could make it

quicker, but in so doing I think we have to be very careful so that

we don’t sacrifice the rights of people to get what they truly deserve under the program.

Mr. MICA. Mr. Burton.

Mr. BURTON. I find that interesting when we have deadlines. My

two grandchildren, we had to file—we found out the week before

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the deadline that they had to file. And if we had gone past that

deadline, I guess we would have had no recourse—the week before.

So, I mean, I am glad you have this concern about being fair to

these people, but if you only have a certain date that you have to

comply by, it kind of leaves people out in the cold.

This is supposed to be a no-fault system, and you keep talking

about litigation. I just don’t understand that. I mean, it was designed to be a no-fault system. Why litigation? Litigation denotes

adversarial problems—an adversarial situation. That doesn’t sound

like no-fault. You can answer that in just 1 second.

How much, Mr. Euler, will it cost to care for an injured child for

the lifetime of that child?

Mr. EULER. It depends on the child, Mr. Chairman.

Mr. BURTON. Give me a rough idea, say, for one that lives to be

25.

Mr. EULER. I can’t. It is very hard to have a hypothetical, because each child is different.

Mr. BURTON. No, but we have had some children here today who

have had some severe problems. I have a severe problem in my

family. We have already laid out several thousand dollars. And I

know that a lot of families can’t afford that. So, what are they to

do?

If the vaccination was responsible for it and we don’t find out for

10 years and the statute or the time period runs out, what are they

to do? Go to SSI?

Mr. EULER. Congress has the ability to change the statutory criteria, which we are charged with implementing. We have already

recommended that the statue be essentially doubled, the statute of

limitations, from 3 years to 6 years.

Mr. BURTON. Why not just take the lid off of it?

Mr. EULER. That is something Congress has the power to do.

Mr. BURTON. Would you think that would be a good idea?

Mr. EULER. I think we would have to consider it. I think every

program has time limits. Every program anywhere——

Mr. BURTON. But you don’t know how a child is going to—I

mean, the child may not have a problem that is visible for 5, 6, 7

years, and then all of sudden the statute has run out, and that

child is ruined for life, and the parent has no resources to take care

of it.

Mr. EULER. The statute begins to run from the onset of the condition, now, whenever that it is. It doesn’t necessarily run from the

date of vaccination, though there can be debate over when that

onset is, but it may be several years out.

Mr. BURTON. Mr. Chairman, I thank you very much. It sounds

like to me we are going to have to come up with some amendments

to the current statute, and we have to do it relatively soon.

Thank you, sir.

Mr. MICA. Thank you. The President in an Executive order in

1996 recommended agencies adopt alternative dispute resolutions

and that we try to proceed in that fashion.

Has the Department of Justice or HHS instituted a formal program of alternate dispute resolution with regard to the Vaccine

Compensation Program?

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Mr. EULER. Much of the process itself has elements of what we

call ADR. For example, I referred in my testimony to that initial

telephone conference that the special master convenes with the petitioner and with Justice counsel. What is done there is the petitioner is advised of the deficiencies in the complaint and how they

can go about fixing it. I am not aware of any other system that

does that. And that type of informal processing exists throughout

the program.

The court, in addition, does in fact take additional ADR steps at

times in the damages phase. If it doesn’t look like it is being

worked out, we have some success getting another special master

to take a look at the case to try to resolve it. That has worked out

well on occasion, and that is sometimes one of the things we do.

But this is clearly a less adversarial, informal process, and there

are not rules of evidence, there is not civil discovery. The idea is

to get all of the information out on the table and then to come to

a resolution for that child’s care. That is what we are trying to do.

That is not an easy process for petitioners, I grant that. They work

hard at it, but sometimes it takes awhile.

Mr. MICA. Mr. Balbier, do you keep a log of the cases that have

been resolved and then how—or when they were initiated and

when they were resolved? Do you have such a log from the time— on each case? Like, this year, you said you resolved, what, X number?

Mr. BALBIER. We have a system, of course, where we input

data—— Mr. MICA. But what I would like—— Mr. BALBIER [continuing]. That tracks the date of the

claimant’s—— Mr. MICA [continuing]. If you could provide us, just get this

year’s or the last year’s cases and get us the date when the claim

was instituted and then was—well, we know when it was resolved—so we could see how much time they were taking up. If you

could provide us with that.

Mr. BALBIER. We do track that, and the average is about 2 years.

[The information referred to follows:]

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196

Mr. MICA. I have additional questions. I do want to also learn

from HHS what you are doing to inform the public about the program. I can’t take any responses at this time, and I am going to

adjourn the hearing. I will leave the record open for at least 3

weeks by unanimous consent request. We will be submitting to

both the Department of Justice and HHS and the program a

lengthy series of questions for response, to be included in the

record.

I do want to thank both of you gentlemen for appearing with us

today and providing information. Also thank the other witnesses

who participated in the hearing.

Hopefully everyone working together—and I have directed staff

to meet within the next week to come up with some legislative

remedies. I know that some have been recommended to the Speaker, and we will consult with Mr. Waxman, Mrs. Mink, and others

who have expressed an interest hopefully to come up with a legislative package that is remedial and hopefully effective.

There being no further business to come before this subcommittee at this time, this meeting is adjourned.

[Whereupon, at 1:57 p.m., the subcommittee was adjourned.]

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