[House Hearing, 106 Congress]
[From the U.S. Government Printing Office]





           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

                                 ______

                    U.S. GOVERNMENT PRINTING OFFICE
66-079 CC                   WASHINGTON : 2000



                     COMMITTEE ON GOVERNMENT REFORM

                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut       ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
STEPHEN HORN, California             PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida                PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia            CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana           ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
JOE SCARBOROUGH, Florida             CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South     DENNIS J. KUCINICH, Ohio
    Carolina                         ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia                    DANNY K. DAVIS, Illinois
DAN MILLER, Florida                  JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
LEE TERRY, Nebraska                  THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois               HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California                             ------
PAUL RYAN, Wisconsin                 BERNARD SANDERS, Vermont 
HELEN CHENOWETH, Idaho                   (Independent)
DAVID VITTER, Louisiana


                      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                    PATSY T. MINK, Hawaii
BENJAMIN A. GILMAN, New York         EDOLPHUS TOWNS, New York
CHRISTOPHER SHAYS, Connecticut       ELIJAH E. CUMMINGS, Maryland
ILEANA ROS-LEHTINEN, Florida         DENNIS J. KUCINICH, Ohio
MARK E. SOUDER, Indiana              ROD R. BLAGOJEVICH, Illinois
STEVEN C. LaTOURETTE, Ohio           JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
DOUG OSE, California                 JANICE D. SCHAKOWSKY, Illinois
DAVID VITTER, Louisiana

                               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





                            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

 
           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.
    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 
unfortunately 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.
    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 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:]
    [GRAPHIC] [TIFF OMITTED] T6079.001
    
    [GRAPHIC] [TIFF OMITTED] T6079.002
    
    [GRAPHIC] [TIFF OMITTED] T6079.003
    
    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.
    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, 2\1/2\ 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.
    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.
    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 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.
    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?
    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 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 3\1/2\ years old, Andrew 
had 84 seizures, the shortest being 15 minutes and the longest 
being 1\1/2\ 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 4\1/2\ 
hours. Standing by helplessly as our son seized for 4\1/2\ 
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.
    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 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 3\1/2\ 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 5\1/2\ and 6\1/2\ 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 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, 
6\1/2\ 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 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.
    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.
    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 re-evaluated.
    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 long-term 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.
    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 6\1/2\ or 
7\1/2\ 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.
    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.
    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 
concerned 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 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?
    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 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 system 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 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 
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.
    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. 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 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 long-term 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-in-fact 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.
    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 consideration 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, provides 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 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.
    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.
    I can't prove causation in a case the way I used to prove 
in contingency 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 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 post-vaccinal 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 post-vaccinal 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 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.
    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 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 vaccine-caused 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 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?
    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 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 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 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 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 expert 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 sensitivity 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----
    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 non-adversarial. 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. 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?
    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.
    [The information referred to follows:]
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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?
    Mr. Balbier. A total of $135 million divided between the 
pre-1988 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 
Government-wide 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.
    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 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?
    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.
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    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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