[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]



 
    THE NATIONAL VACCINE INJURY PROGRAM: IS IT WORKING AS CONGRESS 
                               INTENDED?
=======================================================================


                                HEARINGS

                               before the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION
                               __________

                    NOVEMBER 1 AND DECEMBER 12, 2001
                               __________

                           Serial No. 107-44
                               __________

       Printed for the use of the Committee on Government Reform








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                     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       MAJOR R. OWENS, New York
ILEANA ROS-LEHTINEN, Florida         EDOLPHUS TOWNS, New York
JOHN M. McHUGH, New York             PAUL E. KANJORSKI, Pennsylvania
STEPHEN HORN, California             PATSY T. MINK, Hawaii
JOHN L. MICA, Florida                CAROLYN B. MALONEY, New York
THOMAS M. DAVIS, Virginia            ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
BOB BARR, Georgia                    DENNIS J. KUCINICH, Ohio
DAN MILLER, Florida                  ROD R. BLAGOJEVICH, Illinois
DOUG OSE, California                 DANNY K. DAVIS, Illinois
RON LEWIS, Kentucky                  JOHN F. TIERNEY, Massachusetts
JO ANN DAVIS, Virginia               JIM TURNER, Texas
TODD RUSSELL PLATTS, Pennsylvania    THOMAS H. ALLEN, Maine
DAVE WELDON, Florida                 JANICE D. SCHAKOWSKY, Illinois
CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
ADAM H. PUTNAM, Florida              DIANE E. WATSON, California
C.L. ``BUTCH'' OTTER, Idaho          STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia                      ------
JOHN J. DUNCAN, Tennessee            BERNARD SANDERS, Vermont 
------ ------                            (Independent)


                      Kevin Binger, Staff Director
                 Daniel R. Moll, Deputy Staff Director
                     James C. Wilson, Chief Counsel
                     Robert A. Briggs, Chief Clerk
                 Phil Schiliro, Minority Staff Director











                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on:
    November 1, 2001.............................................     1
    December 12, 2001............................................   135
Statement of:
    Balbier, Thomas E., Jr., Director, Division of Vaccine Injury 
      Compensation, Office of Special Programs, Health Resources 
      and Services Administration, U.S. Department of Health and 
      Human Services; Paul Clinton Harris, Deputy Assistant 
      Attorney General, Civil Division, U.S. Department of 
      Justice, concerning the National Vaccine Injury 
      Compensation Program; and John Euler, Director, National 
      Vaccine Injury Compensation Program, U.S. Department of 
      Justice....................................................   230
    Balbier, Thomas E., Jr., Director, National Vaccine Injury 
      Compensation Program, accompanied by Geoffrey Evans, 
      Medical Director, and David Benor, Office of the General 
      Counsel; and Paul Clinton Harris, Sr., Deputy Assistant 
      Attorney General, Civil Division, U.S. Department of 
      Justice....................................................    58
    Barton, Lori, Albuquerque, NM; Tara Dyer, Knoxville, TN; Joe 
      Holder, Bayonne, NJ; Clifford Shoemaker, LLP, Arlington, 
      VA; and Robert Block, M.D., chairman, Advisory Commission 
      on Childhood Vaccinations, Tulsa, OK.......................   164
    Rogers, Thad, Auburn, AL; Harold Sword, Columbus, OH; and 
      Janet Zuhlke, Satellite Beach, FL..........................    29
Letters, statements, etc., submitted for the record by:
    Balbier, Thomas E., Jr., Director, National Vaccine Injury 
      Compensation Program, prepared statements of..............62, 232
    Barton, Lori, Albuquerque, NM, prepared statement of.........   168
    Block, Robert, M.D., chairman, Advisory Commission on 
      Childhood Vaccinations, Tulsa, OK, prepared statement of...   213
    Burton, Hon. Dan, a Representative in Congress from the State 
      of Indiana, prepared statements of........................ 6, 140
    Clay, Hon. Wm. Lacy, a Representative in Congress from the 
      State of Missouri, prepared statement of...................    27
    Cummings, Hon. Elijah E., a Representative in Congress from 
      the State of Maryland, prepared statement of...............   154
    Duncan, Hon. John, a Representative in Congress from the 
      State of Tennessee, prepared statement of..................   158
    Dyer, Tara, Knoxville, TN, prepared statement of.............   178
    Harris, Paul Clinton, Sr., Deputy Assistant Attorney General, 
      Civil Division, U.S. Department of Justice, prepared 
      statements of............................................ 71, 240
    Holder, Joe, Bayonne, NJ, prepared statement of..............   184
    Morella, Hon. Constance A., a Representative in Congress from 
      the State of Maryland, prepared statements of........... 105, 151
    Rogers, Thad, Auburn, AL, prepared statement of..............    31
    Shoemaker, Clifford, LLP, Arlington, VA, prepared statement 
      of.........................................................   191
    Sword, Harold, Columbus, OH, prepared statement of...........    36
    Waxman, Hon. Henry A., a Representative in Congress from the 
      State of California, prepared statements of.............. 20, 148
    Weldon, Hon. Dave, a Representative in Congress from the 
      State of Florida, prepared statement of....................   106
    Zuhlke, Janet, Satellite Beach, FL, prepared statement of....    43











    THE NATIONAL VACCINE INJURY PROGRAM: IS IT WORKING AS CONGRESS 
                               INTENDED?

                              ----------                              


                       THURSDAY, NOVEMBER 1, 2001

                          House of Representatives,
                            Committee on Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10 a.m., in room 
2154, Rayburn House Office Building, Hon. Dan Burton (chairman 
of the committee) presiding.
    Present: Representatives Burton, Gilman, Morella, Horn, 
Davis of Virginia, Platts, Weldon, Schrock, Duncan, Waxman, 
Norton, Cummings, Kucinich, Tierney, Clay, and Watson.
    Staff present: Kevin Binger, staff director; James C. 
Wilson, chief counsel; David A. Kass, deputy chief counsel; 
Mark Corallo, director of communications; S. Elizabeth Clay and 
John Rowe, professional staff members; Robert A. Briggs, chief 
clerk; Robin Butler, office manager; Elizabeth Crane, 
legislative assistant; Josie Duckett, deputy communications 
director; Joshua Gillespie, deputy chief clerk; Nicholas 
Mutton, assistant to chief counsel; Leneal Scott, computer 
systems manager; Corrine Zaccagnini, systems administrator; 
Sarah Despres, minority counsel; Ellen Rayner, minority chief 
clerk; and Jean Gosa and Earley Green, minority assistant 
clerks.
    Mr. Burton. The Committee on Government Reform will come to 
order.
    A quorum being present, we'll start our business. I ask 
unanimous consent that all Members' and witnesses' written and 
opening statements be included in the record. Without 
objection, so ordered. I ask unanimous consent that all 
articles, exhibits and extraneous or tabular material referred 
to be included in the record. Without objection, so ordered.
    Today we're going to focus on the Government's program for 
compensating families that experience vaccine injuries. We 
spent about 2 years conducting oversight on Federal vaccine 
policies. We've looked at these issues from almost every angle. 
We've looked at the issues related to vaccine safety. Much more 
research needs to be done in this area. We've looked at 
conflicts of interest in vaccine policymaking. The Department 
of Health and Human Services has a real problem in this area 
that we don't believe they're addressing.
    Today we're going to look at the National Vaccine Injury 
Compensation Program. It was created by Congress to compensate 
families when their children are injured by vaccines. Is it 
working the way Congress intended? I think the answer is no.
    I want to make a few preliminary points about the vaccines 
in general. First, vaccines are an important part of our public 
health system. They've saved millions of lives. They've helped 
wipe out crippling diseases. We want children to be protected 
against infectious diseases. Nothing this committee does should 
be interpreted as anti-vaccine.
    Second, we want vaccines to be as safe as possible. No 
matter how good our vaccines are, there's always room for 
improvement. The oral polio vaccine saved thousands of children 
from a crippling disease. It was a good public health tool in 
its time, but it was not perfect. It had a high rate of adverse 
events. By doing the research, a new and better vaccine was 
developed. Today, we're getting the same public health benefit 
with far fewer side effects with the polio vaccine.
    Not enough research is being done in this area. Mercury is 
a good example. For decades, vaccine manufacturers have used 
mercury preservatives in vaccines. In the past, maybe the 
benefits outweighed the risks. But today, there's a consensus 
that mercury, no matter how small the quantity, does not belong 
in vaccines. The truth is, we just don't know what the health 
effects of mercury are, because the research hasn't been done. 
We know that some forms of mercury cause neurological 
disorders.
    There are some groups of scientists that believe that 
Alzheimer's and autism are in part caused by the mercury in the 
vaccines. I want all the Members of Congress to know that the 
vaccine that they're getting for the flu has mercury in it. 
It's called thimerosal. That's a preservative, and some 
scientists believe it does cause, is a major contributing 
factor to neurological disorders. When you go over and get your 
shot, all you have to do is look at the package insert, because 
it does have mercury in it.
    I'm not saying you shouldn't get a flu shot. But I think 
you should be aware that there's a growing body of evidence 
that the mercury does contribute to Alzheimer's and other 
diseases of that type. And it's in the vaccine.
    Not enough research has been done to tell us if the mercury 
preservatives used in vaccines are related to neurological 
problems. But as I said, there's a growing number of scientists 
that believe it is. The Institute of Medicine said that a 
connection is biologically plausible, but there's not enough 
research to know. And we need to do more research to make sure.
    When those of us who have really looked at these issues 
call for more research, and when we say that we should err on 
the side of caution, I hope we won't be accused of trying to 
scare the public. We shouldn't bury our heads in the sand when 
it comes to vaccine safety. The best way to give the American 
people confidence is to do the research so we can tell the 
people that their vaccines are as safe as possible and most 
effective products are as safe as possible.
    The third point I want to make is this. We know that no 
matter how safe a vaccine is, a very small number of people are 
going to be injured. That's a fact. That's why Congress created 
the Vaccine Injury Compensation Program, to provide 
compensation to families when their children are injured. My 
colleague, Mr. Waxman, who I'm very happy is on the committee, 
because he is very familiar with this issue, he wrote the bill 
that created this program 15 years ago. And he deserves a lot 
of credit for that.
    At the time, vaccine manufacturers were faced with a lot of 
lawsuits. They were threatening to leave the market. So that 
would have adversely affected people who needed those vaccines. 
The stability of our vaccine supply was in question. Mr. Waxman 
and others stepped in and created this program, and it took a 
lot of foresight. The program had three basic goals. The first 
goal was to protect vaccine manufacturers from lawsuits. That 
was successful.
    The second goal was to stabilize the supply of vaccines in 
this country. Again, that was a success. The third goal was to 
provide compensation to families in a generous way without 
tying them up in court for years. And on this point, the 
program has not lived up to expectations.
    This system was designed to be generous to families whose 
children were suffering crippling injuries. It was meant to 
provide compensation quickly, without a lot of legal fighting. 
On close calls, the families are supposed to get the benefit of 
the doubt.
    That's not the way the program has been working today. It 
had some successes, but it's also had some failures. If you 
talk to families who have been tied up in this system, it 
sounds like this program has become every bit as adversarial as 
the tort system it replaced. Cases drag on for 6 or 8 or 10 
years. The GAO said that the average case takes 2 years to 
complete.
    A third of the cases take more than 5 years. The Government 
hires teams of medical witnesses to try to disprove families' 
cases. All of the Government's expenses are paid out of the 
trust fund. Families are not reimbursed for their expenses for 
years. We're talking about middle class families who are 
already paying tens of thousands of dollars every year to take 
care of severely injured children.
    We're supposed to be helping these people. But if you talk 
to some of these families, they feel like they've been put 
through the wringer by their own Government. We have some clear 
evidence of overzealous conduct on behalf of the Government. In 
the case of the Sword family, which we're going to hear about 
today, the Special Master called the Justice Department 
lawyer's tactics egregious: ``Respondent's argument of 
independent corroboration from the records is especially 
egregious in a situation such as the instant case in which 
death occurs within 4 hours of vaccination.''
    In the Zuhlke family, one of the special masters recused 
himself from the case because he became so frustrated with the 
Government representative. In a case cited in our committee 
report last year, the Special Master apologized to the family 
for the Government's conduct: ``In the special master's view, 
respondent's counsel's abrasive, tenacious, obstreperous 
litigation tactics were inappropriate in a program that is 
intended to be less adversarial.''
    We have three families here today who are going to talk 
about their struggles under this program. I'd like to talk 
about each one of these cases in detail because they're all so 
compelling. But I don't want to make our witnesses wait any 
longer than is necessary.
    Let me just use the Zuhlke case as an example. Janet 
Zuhlke's daughter received her pre-kindergarten vaccinations in 
1990. Rachel had a severe reaction almost immediately. Within 6 
hours, she was vomiting and she had fever, severe headaches and 
pain in her eyes that made her scream. Within 3 weeks, she was 
in critical condition and she had to be medevaced to the 
hospital at the University of Florida.
    Today Rachel is mentally retarded. She had periodic bouts 
of blindness. She has neurological breakdowns that confine her 
to a wheelchair and she'll need care for the rest of her life. 
A team of medical specialists diagnosed her case as a vaccine-
related encephalopathy. That's a condition that's on the 
vaccine injury table. If you suffer a ``table injury'' you're 
supposed to get compensation almost automatically.
    Well, that's not what happened to the Zuhlkes. This case 
has dragged on for 9 years. The Zuhlkes still haven't received 
one penny from the program.
    The Department of Justice and HHS spent years trying to 
prove that Rachel's illness was caused by a strep infection. 
This case dragged on so long, they went through three special 
masters. As I said earlier, one special master recused himself 
from the case because the Government would not settle. The 
Zuhlke family finally won their case in July of this year, more 
than 9 years after they filed their petition.
    But they're still probably a year away from receiving any 
compensation. For them, the second of the process is just 
kicking in. There's a long period of negotiations to determine 
exactly how much money they're entitled to receive. Janet 
Zuhlke's already spent over $25,000 out of her own pocket to 
care for her daughter and to try to win this case.
    And that was a table injury. This was supposed to be one of 
the easy cases.
    Now, not every family has had an experience this bad. But 
this is not an isolated incident. You hear about these cases 
over and over again. It's just wrong. Put yourself in their 
shoes. You have a child who suffers a terrible injury, maybe 
you have a child who died like Harold Sword did. That takes a 
terrible emotional toll on your family. You're faced with 
hundreds of thousands of dollars in expenses, and on top of 
that, you have to fight the Government, with all of its 
resources, for years to try to get any help.
    Somewhere along the way, this program lost its way. The 
government collects an excise tax on vaccines so it can take 
care of families like the Zuhlkes and the Swords and the 
Rogers. The Government has $1.7 billion in this trust fund, and 
it's growing every year. These families are supposed to get the 
benefit of the doubt. They're supposed to be treated with 
compassion. But instead, they have to fight the Government for 
years to get any help at all.
    Now, the Justice Department and HHS deserve some credit. 
They've recognized that there are some problems. They've even 
backed some reforms that the Congress has not yet approved. 
They've supported a longer statute of limitations, and that's 
good. They've supported legislation to authorize interim 
payments to families when they win the first phase. And that's 
good. These are reforms Congress should enact immediately. 
Congressman Weldon, on our committee, Dr. Weldon, has 
introduced legislation that addresses these problems and many 
others. It's a good bill and I'm a co-sponsor of it, and I want 
to thank Dr. Weldon for his hard work on this issue.
    But the most important reform does not require legislation. 
It requires the Justice Department to take a long, hard look at 
the way it does business in this area. And that goes for HHS, 
too. They have to use some common sense. Close calls are 
supposed to go to the families. The Government is not supposed 
to fight them tooth and nail. Some of these cases don't even 
look like close calls, and yet the Government fights them for 
years. That has to stop.
    Let me conclude by saying this. Vaccinations are important. 
We wanted children to be protected against childhood diseases. 
We should keep trying to make vaccines safer. Most kids who get 
vaccinated do just fine; but there are cases where children are 
injured, adults as well. And those are terrible, terrible 
situations for the families. Instead of treating them like 
opponents, we have to start treating them with a little more 
compassion. That's what Congress intended when we created this 
program, and that's what Mr. Waxman intended when he supported 
and sponsored the legislation. And that's what we want to see 
happen.
    I want to thank Mr. Sword, Ms. Zuhlke and Mr. Rogers for 
being here today. We'll be very interested in what you have to 
say. And I also want to thank the representatives from the 
Justice Department and HHS for being here. I hope they can 
offer us some encouragement that they want to address these 
problems I just mentioned.
    And with that I yield to Mr. Waxman.
    [The prepared statement of Hon. Dan Burton follows:]
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    Mr. Waxman. Mr. Gilman has to go to the White House, and 
I'd like to let him go before me.
    Mr. Burton. Go ahead, Mr. Gilman.
    Mr. Gilman. Thank you, Chairman Burton. I want to thank 
Ranking Member Waxman for yielding me this time.
    I welcome the panelists and I want to thank Chairman Burton 
for arranging this hearing, which is so important to so many of 
our people throughout the Nation. Chairman Burton and Ranking 
Member Waxman, you're to be commended for your concern about 
these important problems. We look forward to hearing from the 
panelists As our committee continues to examine the 
effectiveness of the National Vaccine Injury Compensation 
Program.
    In 1986, when Mr. Waxman farsightedly had the Congress 
adopt the National Childhood Vaccine Injury Act, it intended to 
provide fair compensation to any individuals harmed by vaccines 
while making certain that the vaccine manufacturers would 
continue to supply and create safe vaccines to the American 
public. Instead, this program, jointly administered by the 
Department of Justice and HHS, has regrettably become bogged 
down in litigation, with cases lasting years, as our good 
chairman has noted, facing numerous levels of appeal before any 
final decisions are made.
    This program initially, as Mr. Waxman introduced it, was 
designed to provide fair, expedited compensation to those who 
may have suffered any vaccine injury. During my years in the 
Congress, I've been contacted by a number of families in my 
district, all of whom have experienced varying levels of 
difficulty and delays with their claims before the compensation 
program, ranging from being forced to engage in long, drawn-out 
court battles to outright denial of the claims due to 
administrative changes in definitions and in criteria.
    One such example, Mr. Chairman, is Tommy Sansone, Jr. The 
family of Tommy Sansone, Jr., a former constituent and a police 
officer, has been trying to receive compensation for the 
lingering and devastating effects of a DPT vaccine he received 
when he was only 6 months old. His family attempted to file a 
claim immediately after the son developed a severe, chronic 
seizure disorder less than 2 weeks after receiving the vaccine. 
Regrettably, they were told that before a claim can be filed, 
the family needs to spend more than $1,000 in non-reimbursable 
vaccine related expenses before doing so.
    Since Tommy was covered by his father's insurance plan, it 
took several months before Sansone's met that monetary 
requirement. By that time, however, the criteria for the DPT 
vaccine had been changed, eliminating seizures from the table 
of related side effects. For 10 years, a substantial percentage 
of those with brain damage and other symptoms were recognized 
to be DPT injuries. But by 1985, the year in which Tommy's 
claim was made, it was no longer recognized.
    These new definitions have had unintended consequences, 
using criteria that is so strict that the restitution fund pays 
fewer claims than ever before, despite the fact that there's 
over $1.7 billion, capital B, $1.7 billion, in that fund today. 
As a result, families of children like Tommy find it virtually 
impossible to win a claim in the Vaccine Injury Compensation 
Program, another unintended consequence. That was over 6 years 
ago, and thousands of dollars in medical expenses later.
    Congress envisioned that the National Vaccine Injury 
Compensation Program would be simple, would be straightforward 
and more streamlined to avoid unnecessary typical litigation. 
But somehow the congressional intent has been lost along the 
way.
    Tommy faces a lifetime of crippling seizures and mounting 
medical expenses, in addition to the emotional strain on him 
and his family. Hopefully, this hearing will lead to necessary 
adjustments to the program and finally help children like Tommy 
receive the compensation to which they are entitled.
    Mr. Chairman, again I thank you for conducting this 
hearing, and Mr. Waxman, we thank you for adopting this measure 
initially, but hopefully we can get it back on the right track. 
Thank you, Mr. Chairman.
    Mr. Burton. Mr. Gilman, you might take a look at Dr. 
Weldon's legislation, because he has a bill that might help 
correct some of that.
    Mr. Gilman. Thank you. I look forward to looking at it.
    Mr. Burton. Mr. Waxman.
    Mr. Waxman. Thank you very much, Mr. Chairman, for holding 
this oversight hearing on the vaccine compensation program. I 
feel a certain sense of pride as the author of that bill 15 
years ago. There have been some successes with that legislation 
that are undeniable, and I think we're going to hear some 
questions raised today about problems in the way the vaccine 
compensation system has been implemented.
    Let me give some background and put this in perspective. In 
1987, when Congress passed the Vaccine Injury Compensation Act, 
pharmaceutical companies were threatening to leave the business 
of manufacturing childhood vaccines, citing among other 
reasons, that the increased litigation was driving them out of 
producing these vaccines. The United States was facing the very 
real possibility that we would experience a resurgence of 
devastating illnesses like polio, which is a debilitating and 
often fatal disease that infected as many as 20,000 people in 
some years, or measles, a disease that continues to kill 
900,000 people worldwide even today.
    So in response to this potential public health crisis, 
Congress created the Vaccine Injury Compensation Program. The 
purpose of the program was threefold. First, to be a no-fault 
program to compensate people from the rare but sometimes 
serious side effects of vaccines. Let me underscore that. When 
you immunize large numbers of people, there are going to be 
some rare cases of adverse consequences, very serious adverse 
consequences. And we have to acknowledge that reality there.
    In that case, we decided that we must compensate those 
people. We mandate the vaccinations, for the most part, for all 
the children in this country, as a public health preventative. 
So if somebody's injured, we ought to make sure that person is 
compensated. We don't take away their right to sue. But we have 
a compensation system that offers them an alternative to going 
into court.
    Our second objective was to lower the number of lawsuits 
against vaccine companies in order to encourage these companies 
to stay in the business. And of course, to ensure that we had a 
healthy domestic supply of vaccines. And the third purpose of 
the bill was to allay parents' concerns about vaccine safety so 
that parents would continue to have their children vaccinated.
    Now, in most respects this program is working. Immunization 
rates are high. We rarely see outbreaks of vaccine preventable 
disease like polio or measles. While some vaccine manufacturers 
have left the vaccine business, they cannot cite liability as a 
reason for leaving. And finally, people seem generally 
satisfied with the awards they get under the Vaccine Injury 
Compensation Program.
    The act Congress passed allowed people to reject their 
awards and sue the vaccine manufacturers once they had gone 
through the program. Very few people have gone to court. Most 
have received compensation through the compensation system and 
have been quite satisfied with it.
    Today, we're going to hear from some people who went 
through the compensation system and did not receive an award to 
compensate them. We are to try to understand why that took 
place. There seems to be a greater litigiousness on the part of 
the Department of Justice. I'd like to know why. The purpose of 
the program was not to replace the tort system with an 
adversarial litigious framework, but to move to a more reasoned 
source for resolving the claim and compensating those who are 
entitled to be compensated.
    Now, there is the question, about whether injuries that 
people have suffered are related to the vaccine? Because if you 
have people come forward and say, well, I had a vaccination and 
then I had some terrible result, but you can't show that it was 
related to the vaccine, that's not the purpose of the vaccine 
compensation system to award people money if there's no 
connection between the two.
    So one of the issues that we have to look at is, what is 
the standard of proof. Well, we have a table of known reactions 
to some of these vaccines, rare, but they do occur. And in that 
situation, we provide automatic compensation for those who are 
suffering from what's called table injuries.
    But then you have people who have adverse effects that are 
not listed. And should they be compensated and what burden of 
proof would they have in order to make their case to the 
committee that decides the issue. And the present law says that 
they have to have a preponderance of evidence to show that 
their injuries were related to the vaccine.
    Mr. Weldon has suggested, in his legislation, that we have 
a justifiable belief standard. As I understand the standard he 
set in place, would be to change the burden of proof 
requirement from the traditional preponderance of the evidence 
standard to submitting evidence sufficient to justify a belief 
by a fair and impartial individual that petitioner's claims are 
well grounded.
    Now, that's a very different and lower standard. We ought 
to take a look at it and examine it. I was impressed by the 
fact that the Bush administration representatives today are 
going to tell us that they feel very uneasy with that standard. 
They feel it moves us away from science, a scientific 
evaluation of the connection between the injury and the 
vaccine. They feel that it's too low a standard and would 
compensate people who wouldn't otherwise be compensated.
    Now, I have to say, I'm a liberal Democrat. I like to see 
people compensated if they're hurt. But if you open this thing 
too wide open, if anybody comes in and has a claim, and they 
can just say, I can show that a person should be convinced that 
there's a relationship between my injury and the vaccine, then 
maybe that will open things too broadly. So I want us to look 
at that issue.
    We've heard complaints about the program. Specifically 
today we're going to hear from people who feel they weren't 
fairly treated. But we've also heard complaints, other 
complaints, specifically about the statute of limitations, the 
fact that the program doesn't allow for interim payments for 
attorneys costs, the length of time it takes to resolve cases, 
and the difficulty of resolving off-table injury cases. So I'm 
pleased we're going to hear from people who can shed some light 
on these issues. Their insights as we look at their experiences 
will help us understand how this program can be improved.
    I'm also pleased that we are going to hear from the 
administration because they've expressed support for certain 
changes in the program, including increasing the statute of 
limitations and allowing for interim payments to petitioners' 
attorneys for their costs. I think those are obvious important 
steps in easing the burden of parents to get compensation for 
vaccine injuries, and I look forward to working with this 
administration and my colleagues in the Congress in making some 
of these changes.
    But as we discuss this vaccine injury program, we have to 
be mindful that it's impossible to separate the issue of the 
Vaccine Injury Compensation Program from the issue of vaccine 
supply. This is why I, along with Senator Kennedy and Senator 
Frist, among others, have asked the General Accounting Office 
to study why vaccine companies are leaving the business.
    Currently, the United States is experiencing shortages of 
childhood vaccines. My office has gotten calls from doctors who 
cannot get tetanus vaccine, even for their high risk patients. 
And there are spot shortages of the DTAP vaccine, which 
protects kids against diphtheria, pertussis, or whooping cough, 
as well as against tetanus. These are serious childhood 
diseases. We don't want a resurgence of them in the United 
States. Some providers are also experiencing shortages of 
pneumococcal conjugate vaccine, which protects children against 
diseases caused by pneumococcal bacteria, including meningitis, 
which can be fatal.
    So I think we want to find out what's going on in that 
area, why we are facing these shortages.
    There's also an issue of the flu vaccine. On average, 
20,000 people nationwide die from the flu yearly. Secretary 
Thompson is urging people to get flu vaccines this year, 
because the symptoms from the flu are the same as from anthrax. 
However, we currently don't have enough flu vaccine to immunize 
everyone.
    Finally, now that we're facing actual bioterrorism, there's 
an increasing concern specifically about our supplies of 
smallpox and anthrax vaccines. There is an anthrax vaccine, 
there is a smallpox vaccine. I've read media accounts of 
doctors being flooded with phone calls form people saying they 
want to take these vaccines. At this time it would not be 
prudent to have universal vaccination against smallpox or 
anthrax. However, I'm sure it would be very reassuring to the 
public to know that if we needed them, we had adequate supplies 
of these vaccines. So we ought to be simply stockpiling and 
manufacturing at a very fast rate both vaccines.
    And let me point out that there's something that sometimes 
comes with being around a long period of time. When I first got 
elected to Congress, in 1974, in 1975 my first year here, the 
Ford administration believed that we were facing a worldwide 
epidemic of what was known as the swine flu. And they 
immediately moved forward to have every American immunized 
against this swine flu.
    Well, people lined up to be immunized. What they didn't 
recognize, and we always have to keep in mind, is that when you 
have mass immunization, there are going to be some adverse 
events. So some people, intending to prevent this swine flu 
from attacking them, came down with some very serious side 
effects that we didn't anticipate. Guillain-Barre syndrome, 
which caused paralysis in individuals, was creeping up in 
numbers as a result of this mass immunization. So I say that to 
point out, when people say, well, why don't we have everyone 
vaccinated for anthrax or everyone vaccinated for smallpox, 
that we have to be very concerned about the increase in the 
adverse events, serious adverse events. And we have to balance 
the risks and the benefit.
    It turned out, we never did get that swine flu epidemic. 
But we did get some of those terrible side effects.
    In the case of childhood vaccines, we know that without 
immunizations on a mass scale, we will get a resurgence of 
those diseases. That's why we need to have mass immunizations. 
But if we're going to have some of those rare terrible adverse 
events there are some adverse events that are not as serious, 
but those serious adverse events ought to be the basis for 
compensation. And that was the purpose for this compensation 
system.
    I mention these specific examples of vaccine supply 
problems to remind us that the Vaccine Injury Compensation 
Program serves a very important function in helping to ensure 
the security of the vaccine supply. Making sure we have 
adequate supplies of vaccine is a public health priority, 
especially now with the looming fear of bioterrorism. Our goal 
should be to further shore up our fragile vaccine 
infrastructure with safe, effective vaccines and to reassure 
the public that if they do suffer from the rare but very real 
side effects of vaccines, that they will be fairly and quickly 
compensated.
    I want to thank all the witnesses for being here today. 
Unfortunately, what happens often in our congressional day is 
that we have many things scheduled at the same time. When I was 
chairman of the Health and Environment Subcommittee, I could 
schedule the hearings to fit my schedule, and I could plan to 
be there throughout the hearing. Now I'm experiencing what the 
majority used to experience when they were in the minority, our 
day is not up to us to schedule, it's up to those other 
committee chairmen and those on the floor to set where we have 
to be. Today I find myself having to be at a number of places 
at the same time.
    I want to assure all the witnesses that if I'm not here 
personally, I will review their testimony. My staff is here to 
hear them and we will work with our colleagues in trying to 
figure out how to make those necessary changes in the vaccine 
compensation program to accomplish the goals we had 15 years 
ago, and the goals we still have today.
    Thank you, Mr. Chairman, for giving me this time to make 
this lengthy statement.
    [The prepared statement of Hon. Henry A. Waxman follows:]
    [GRAPHIC] [TIFF OMITTED] T7527.009
    
    [GRAPHIC] [TIFF OMITTED] T7527.010
    
    Mr. Burton. Well, as the author of the legislation, I think 
you probably know as much or more about this than anybody, and 
we appreciate what you've done and hopefully what you can help 
us do in the future.
    Mr. Horn.
    Mr. Horn. Mr. Chairman, I commend you for getting these 
cases, and I would suggest that we move on and get to 
questioning and not opening statements.
    Mr. Burton. Do you yield your time, then?
    Mr. Horn. Yes.
    Mr. Burton. Mr. Kucinich.
    Mr. Kucinich. I want to say briefly, first of all, I too 
have a simultaneous committee hearing going on, and I'm one of 
the Democrats who is needed over there. I'm going to try to 
come back to this hearing.
    But I want to say that for those who are here to testify, I 
think that it's important for the country to hear what you have 
to say. The efforts that have been made by Mr. Waxman, to 
assure that if injuries do occur there will be compensation, is 
something that I think this Congress needs to be mindful of 
with respect to the moral obligation of Government to 
compensate people if they are injured through participating in 
a Government mandated program, or a program that Government is 
advocating wide subscription by the public.
    Certainly in this era, vaccinations take on an even greater 
concern with the mass public. I think that for those of you who 
have had families and loved ones, particularly who have 
suffered an injury, it pains me as a Member of Congress to even 
have the thought that our Government could be engaging in 
litigation to contest legitimate claims. And it's something 
that ought to concern everyone here.
    So I appreciate your presence here. I know that along with 
Mr. Waxman, I'm going to be following very carefully the 
results of the testimony today. I look forward to the 
proceedings. And I thank the Chair for calling the hearing.
    Mr. Burton. Thank you, Mr. Kucinich.
    Dr. Weldon.
    Dr. Weldon. Thank you, Mr. Chairman.
    I want to just say that normally I wholeheartedly endorse 
the sentiments of Mr. Horn at hearings. I think it's important 
that we get to the testimony as quickly as possible.
    However, I want to just make two important comments. No. 1, 
I want to welcome Janet Zuhlke, we're going to hear testimony 
from her. She's a courageous lady. The chairman has outlined 
some of the details of her ordeal. I'm sure she'll be going 
into that in more detail in her testimony. And I hope one of 
the things that we can get at in this hearing is why does it 
take so long for some of these cases to work through the 
system.
    The other point I want to make is I was practicing medicine 
when the original bill was passed. I want to commend the 
ranking member, Mr. Waxman. It was, I think, a badly needed 
piece of legislation. And at the time, from my perspective, it 
was a well crafted piece of legislation.
    I think one of the fundamental problems with the system is 
that, and no offense to my attorney friends on the committee, 
it's just that we've allowed attorneys the opportunity to 
manage a lot of this. I think changing the burden of proof 
provisions in law is needed. I'm certainly open to discussions 
of modifying my language. I'm quite pleased that the 
administration has endorsed many of the provisions in the bill.
    And I just want to point out that my bill is definitely 
very bipartisan. It is supported by a very broad spectrum of 
Members of the House of Representatives. Any piece of 
legislation that could have Chairman Burton, myself, Jerry 
Nadler and Barney Frank on the same piece of legislation has to 
be correctly labeled as a bipartisan piece of legislation.
    And frankly, I think if we all sit down and try to work 
through some of the details on this issue, in good faith, we 
should be able to get this bill marked up in Commerce and 
possibly pass it out of the House of Representatives on 
suspension. There's pretty broad based agreement, I think, that 
some changes need to be made.
    So I'm looking forward to the testimony of all our 
witnesses, and certainly my constituent from Satellite Beach, 
Janet Zuhlke. And I yield back. Thank you, Mr. Chairman.
    Mr. Burton. Thank you, Dr. Weldon.
    Ms. Watson, did you have a comment?
    Ms. Watson. No, thank you, Mr. Chairman.
    Mr. Burton. Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman.
    This committee has held several hearings on the issue of 
vaccinations, adverse reactions to vaccinations, the Vaccine 
Injury Compensation Program, vaccinations for our military 
personnel and FDA regulations of vaccines. The purpose of 
today's hearing is to review the Department of Justice's and 
the Department of Health and Human Resources' implementation of 
the Vaccine Injury Compensation Program.
    I fully believe in vaccinations. Vaccines are responsible 
for the eradication of some diseases that are common in this 
country. Further, in light of recent events, there has been 
increased talk of vaccinating lab technicians, public health 
workers, law enforcement officers, clean-up crews and even 
postal workers as the threat of anthrax exposure widens.
    Congress adopted the National Childhood Vaccine Injury Act, 
which established the Vaccine Injury Compensation Program. The 
program was established for three main reasons. One, to fairly 
and quickly compensate children who were injured by vaccines; 
two, to decrease litigation filed against vaccine manufacturers 
in order to encourage them to stay in the vaccine market, thus 
ensuring a sufficient vaccine supply; and three, to reassure 
parents so that they would continue to immunize their children.
    Mr. Chairman, I believe the program is working as Mr. 
Waxman, the author of the original legislation in Congress 
intended when it passed it in 1986. Of course, there are some 
people not fully satisfied with the program. Perhaps the 
statute of limitations is too short and perhaps it does take 
too long to compensate claimants.
    However, the program has been successful in its policy 
goals of ensuring vaccine supply and establishing a program for 
individuals and families injured by childhood vaccines. 
Congress was responsive to growing concerns of fears about 
vaccine safety and the vaccine preventable diseases by creating 
a no-fault compensation program for people who were injured by 
vaccines that are part of the routine childhood immunization 
schedule.
    Finally, Congress needs to continue its role to guarantee 
the safety of vaccines and to ensure that the goals of the 
program are met in the future. Besides holding hearings on this 
very important issue, the committee and Congress can update 
their Web sites and other forms of communication for easy 
access to information. No vaccine is perfectly safe, but 
vaccines are responsible for preventing the spreading of 
infectious diseases and in some cases, eliminating them 
altogether.
    Disease prevention is the key to public health. Parents 
need to be fully informed of the possible adverse effects and 
alternate immunization schedules. This can be accomplished by 
their health care personnel or through useful Web sites and 
timely communication.
    I look forward to hearing from all of our witnesses today. 
I know that they are all moving in the right direction and I 
thank them for being here.
    With that, I yield back.
    Mr. Burton. Thank you, Mr. Cummings.
    Mrs. Davis.
    Mrs. Davis of Virginia. Thank you, Mr. Chairman.
    Just to show that we work in a bipartisan manner, I have 
three committee meetings going on at 11 o'clock. So I will have 
to excuse myself, and I have to apologize that I won't get to 
hear the panel. But I will come back to the hearing as soon as 
I can.
    Mr. Burton. We'll give you information on the hearing as 
well.
    Mrs. Davis of Virginia. Thank you.
    Mr. Burton. Mr. Duncan.
    Mr. Duncan. Thank you, Mr. Chairman.
    Very briefly, I want to first of all thank you for calling 
this very important hearing. I have some great concern about 
these vaccinations. I remember Shay Beaker, a woman coming to 
see me at a constituent day in Lenore City, TN, and telling me 
about her son who was perfectly healthy until he was close to 1 
year in age, and she took him for a DPT vaccination. At the 
time she came to see me, he was 2 years old, weighed 22 pounds, 
had continuous convulsions and seizures, projectile vomiting 
and all sorts of horrible things on a daily basis.
    The Dyer family from Knoxville, TN, came to me and told me 
about their son, Andy Dyer, who's now 10 years old. When he was 
2, he received a DPT vaccination and his family has been unable 
to get compensation, although there were 600 incidents from his 
batch 78 claims from his lot, 44 of them in Tennessee, 
including 3 deaths. This is a young boy who can't walk, can't 
talk, requires full time care, on a 24 hour basis. His family 
was told that his 48 hour symptoms were not severe enough, 
although he stopped suckling, he started continually flicking 
his ear and having small seizures right after this vaccination.
    So I have great concern, and I'm looking forward to hearing 
from these witnesses. I think this is a program that is crying 
out for reform, just based on what I've heard from my 
constituents and from other people from around the country. So 
I look forward to the testimony of the witnesses, and I thank 
you for allowing me to be part of this hearing.
    Mr. Burton. Thank you, Mr. Duncan.
    Ms. Norton, do you have an opening comment?
    Ms. Norton. Mr. Chairman, only to say that I think this is 
an important and timely hearing that you're holding. At a time 
when terrorism must cause us to encourage people to 
participate, especially as to children, and programs that 
provide needed vaccines, compensation in case of a mishap is 
very important.
    But I hope that given the fact that we are probably going 
to see more and more children and more and more adults facing 
the necessity to take vaccines, I hope that this war we are in 
will spur us into more research, so that whatever fear there is 
of those vaccines that have caused problems to a few will not 
become a more generalized fear at a time when frankly, we can't 
afford that kind of fear.
    But part of the reason for that fear is that these vaccines 
are not always as perfected as they might be. I think our 
country has done an extraordinary job, given the small number 
of injuries and deaths which in fact come out of vaccinations. 
Medical science is not perfect, and science is not perfect. But 
we have certainly gone very far in using vaccines to protect 
our own public.
    Now as we hear that it may become necessary once again to 
vaccinate people against smallpox, and we know that there are, 
for a very small number of people, some serious side effects, 
we need to work harder than ever on making sure that those side 
effects are conquered and disappear, particularly when it comes 
to something like smallpox. We can't afford to have people 
saying against the smallpox, sorry, I don't want that vaccine. 
Because as we learned, one person unvaccinated can do great 
harm.
    But the only way to instill confidence is not only to say 
to people, don't worry, if something happens, if your child 
dies, if your child is incapacitated, then there's compensation 
for you. That's the least we can do. We ought to use what we're 
going through now to do the kinds of stepped up research that 
will take away the fear, because we have reduced almost 
entirely the side effects and certainly the serious side 
effects or death from vaccine injury.
    Thank you again, Mr. Chairman, for this important and 
timely hearing.
    Mr. Burton. Thank you, Ms. Norton.
    Mr. Schrock.
    Mr. Schrock. Mr. Chairman, I concur with Mr. Horn's opinion 
about opening statements, because we have to vote. I'm ready to 
hear the panel members. I'll have no opening statement.
    Mr. Burton. Thank you, Mr. Schrock.
    Mr. Clay, do you have any comments?
    Mr. Clay. Yes, thank you, Mr. Chairman. It's a privilege to 
meet with the committee today.
    I especially welcome the parents and spouses who are 
witnesses today. It is noted that all of the parents and 
spouses on the panel have family members who have suffered 
adverse effects as a result of vaccination. Additionally, I 
welcome all other witnesses of the panels.
    Mr. Chairman, my No. 1 focus, while I am in office, is 
children. I'm a father, as you are, and I'm especially grateful 
that you extend that parental concern through this committee. 
This hearing examines the injury compensation program and has 
the purpose of fairly and quickly compensating children who are 
injured by vaccines to decrease litigation against 
manufacturers, so as to encourage them to stay in the vaccine 
market.
    Overall, the vaccine injury program has worked well. There 
are still some areas of concern within the program that must be 
adjusted. We know that the program is not perfect. The intent 
of this hearing today is to address those areas that need 
adjustment. And at this point, Mr. Chairman, I ask unanimous 
consent to enter this statement into the record.
    Mr. Burton. Without objection, so ordered. Thank you, Mr. 
Clay.
    [The prepared statement of Hon. Wm. Lacy Clay follows:]
    [GRAPHIC] [TIFF OMITTED] T7527.011
    
    [GRAPHIC] [TIFF OMITTED] T7527.012
    
    Mr. Burton. I apologize to the panels, we will get to you 
just as quickly as this vote is concluded. We have a vote on 
the floor, so we will recess the committee and be back here in 
about 10 or 15 minutes and we'll go to the first panel 
immediately upon our arrival. Thank you.
    We stand in recess.
    [Recess.]
    Mr. Burton. The committee will come to order.
    I'd like to now have the first witness panel, Mrs. Janet 
Zuhlke, Mr. Harold Sword and Thad Rogers, please come to the 
witness table.
    It's customary that we swear in our witnesses, so would you 
raise your right hands, please?
    [Witnesses sworn.]
    Mr. Burton. Be seated.
    I think Dr. Weldon wants to introduce you, Ms. Zuhlke, so 
we'll let you speak after he returns. He's on his way back. So 
we'll start with Mr. Rogers. Do you have an opening statement, 
Mr. Rogers? If you could, we want to ask questions, so if you 
could keep your statements as close to 5 minutes as possible, 
we'd appreciate it. But go ahead, take your time. Mr. Rogers.

STATEMENTS OF THAD ROGERS, AUBURN, AL; HAROLD SWORD, COLUMBUS, 
           OH; AND JANET ZUHLKE, SATELLITE BEACH, FL

    Mr. Rogers. I'm glad we finally got to be here, because you 
all kept postponing everything on us, and we finally got to 
make it.
    My name is Thad Rogers, and my wife was--her life was 
destroyed by a tetanus shot--tetanus vaccine. Before the 
vaccine, my wife bowled, coached basketball and softball, and 
played tennis with our daughter. She was just a normal, healthy 
human being.
    She did the motherly thing, drove our son and daughter to 
activities they were involved in, basketball, softball, soccer, 
tennis, Boy Scouts and Girl Scouts. She did all the household 
activities like a wife would do. We also fished as a family, we 
did everything together as a family.
    My wife had a vaccine on February 15, 1991. During the 
summer of 1991, she became unable to drive or do any kind of 
household work. I had to start taking the kids to the 
activities and learn how to do housework and cook and do 
everything else most husbands don't know how to do. At this 
time, my wife's health was getting worse. Her body was just 
deteriorating.
    We took our last family vacation in the summer of 1996. 
Ever since then, she has not been able to get out of bed by 
herself or basically leave the house. She's in diapers. And 
right now, she's on a catheter, because she's on a special air 
bed. Someone has to be with her around the clock to feed her, 
give her medicine, change the diaper, empty the catheter bag.
    Since 1997, she's had bed baths, hasn't been able to take a 
full bath basically since she's been sick. And my kids, they 
help take care of my wife when I'm at work. Our daughter is in 
her 4th year of college and our son is in his 2nd year. Soon 
they'll be starting their own lives, and like I said, they help 
me take care of her.
    In January 2001, my wife got a bed sore. She's been in a 
special air bed since then, has not been out of it since 
January. The bed sore requires dressing twice a day to twice a 
week, whenever it's necessary. Generally, life with her has 
been extremely hard. I guess you'd say she's real hard to get 
along with because of the illness. She snaps at everybody, 
this, that and the other. It's just been hard, it really has.
    That's all.
    [The prepared statement of Mr. Rogers follows:]
    [GRAPHIC] [TIFF OMITTED] T7527.013
    
    Mr. Burton. Did you want to make any comment, Mr. Rogers, 
about the compensation fund at all? Did you receive anything 
from the compensation fund, for the damage that was done by the 
vaccine? Did you receive any money from them?
    Mr. Rogers. We have not received anything.
    Mr. Burton. Have you applied for that?
    Mr. Rogers. We filed in 1994.
    Mr. Burton. What happened? Can you just tell us a little 
bit about that?
    Mr. Rogers. Well, you go through the process, and we had a 
phone conference with a special master and different lawyers. 
But in June 2000, we got word that the court concluded that my 
wife was entitled for help. But of course, they needed to know, 
I guess you'd say like dollars and cents, what was required to 
take care of her. Because I've been taking care of her out of 
my pocket the whole time, except for the insurance part.
    And in September 2001, the case was appealed. And we 
haven't heard anything since then.
    Mr. Burton. OK, we'll ask you some questions about that in 
just a few minutes.
    Mr. Sword.
    Mr. Sword. Thank you, Mr. Chairman.
    My name is Harold Sword. I am a lifetime resident of Ohio, 
a product of Ohio schools and colleges, a veteran of the U.S. 
Navy, father of six and grandparent of nine. Following the Navy 
I served a 6-year union apprenticeship, attended school while 
raising my family and I have worked for 40 years in the 
newspaper printing industry.
    Before I begin, I would like to thank the committee for its 
work and attention to vaccine injury. I would also like to say 
that I have no bias against vaccine as a medical treatment as 
long as it is safe. When vaccine produces something other than 
safe, I think we are all diminished.
    I'm here to discuss vaccine injury because my daughter, 
Natalie Nicole Sword, died of vaccine injury on her birthday at 
3 months of age on May 13, 1975, just 4 hours after a childhood 
DPT vaccination as part of a normal 3 month exam by her doctor. 
At the time of Natalie's death, there were no requirements to 
warn parents of adverse vaccine reactions, despite 30 years of 
documented medical knowledge and research going back into the 
1940's of the dangers. We were told, ``she will be sleepy and 
that is normal.''
    Consequently, after leaving the doctors' office, on the 
trip home that included a quick stop for ice cream and to pick 
up a grape vine, we drove near or past seven hospitals and 
nearly a dozen other emergency medical sites on the route home. 
Natalie never awoke from the deepening slumber that started 
around noon while still in the doctor's office. Unconcerned 
with the slumber, we allowed her to sleep next to us in a 
bassinet before discovering Natalie not breathing and blue.
    During our frantic efforts to revive Natalie, I spoke twice 
to her doctor by phone, commenting to him, ``there was 
something in that shot that caused a reaction.'' Just 4 hours 
after his examination of Natalie, her doctor's immediate 
response to me was denial, saying, ``No, it wouldn't be the 
vaccine, call me as soon as you get to the hospital.''
    The hospital offered no opinion on cause after talking to 
the doctor upon our arrival in the unequipped county sheriff's 
emergency vehicle through miles of major highway construction. 
That denial continued in a meeting to review the cause of death 
with Natalie's doctor 2 weeks later, following the autopsy.
    Sadly, and outrageously, 30 years after a published article 
on the vaccine deaths of twin boys in the 1940's, Natalie had 
died a similar death without warning. Who is at risk, how to 
know, and is there ever a ``morally acceptable'' risk of death 
or injury to any child, even as a well intended protection, but 
especially without ever knowing of the risk?
    Yet, completely ignoring the vaccine, we were told by the 
doctor that performed the autopsy, the coroner, physician and 
public health officials that the cause of Natalie's death was 
something that we had never heard of called SIDS, sudden infant 
death syndrome. Webster's dictionary describes SIDS as being an 
unknown cause.
    However rare, effected families have both a right and a 
real need to know the truth about vaccine problems. Morality 
and law should require accurate reporting of cause in public 
records when vaccines could be a factor in any injury or death, 
and information should be provided on the vaccine injury 
program. More accurate reporting alone could help reduce costs 
and controversy in the vaccine injury claims.
    In Natalie's case, it was 15 years before we even started 
to learn the truth, and then it was a result of chance, when a 
co-worker who was deaf noticed a wire story of a deadline for 
filing vaccine injury claims as we worked on the next newspaper 
edition. Prior to that article, I knew nothing about a vaccine 
injury program. I had lived with my suspicions, attending SIDS 
support groups alone, because Natalie's mother had a whole 
different approach to her grief.
    I found SIDS logic did not work for me. Although I had 
strong doubts about the ``SIDS cause of death'' ruling, I had 
not sought legal counsel. Filing suit seemed to be an 
impossible option because of the SIDS ruling. I did not want to 
complicate our grief, did not want to hurt the doctor, feeling 
that nothing we could do would bring Natalie back.
    I now suspect many people have reacted that way, contrary 
to Government agency adversarial attitudes toward those who 
managed to discover the Vaccine Injury Compensation Program and 
file claims. Once we found the program late in July, I 
collected the information and suit was filed near the end of 
the deadline.
    However, the suits were separated into two classes by time, 
and there were many suits filed in the pre-1988, creating a 
huge backlog of cases. From the outset, that volume was a 
problem for everyone. How that was handled was to wait for the 
system to get to your case. By the end, for our claim and 
others, it became an uneven legal field, because attorney fees 
and expenses for expert witnesses and awards all remained under 
a cap of mid-1980 dollars, and inflation eroded all three.
    The inflation erosion of attorney fees and expert witnesses 
allowance created limits on resources for claimants that were 
in the system for the longest time and also altered the 
equality of the award for those who had to endure to the end. 
Meanwhile, as far as I knew, there were no similar limits on 
Government's ability to contest claims. Could that happen again 
if mass vaccines had to occur for any reason?
    While time and adversity were problems for the claimants 
due to the specific limits, time and adversity became a 
windfall for what became the other side. For my family, there 
developed a clear sense of a ``betrayal of trust'' by our 
Government's agents as time passed. Advocates and other 
claimants I came in contact with believed Government was 
supposed to conduct the Vaccine Compensation Program as 
adversarial, timely and generous. That was not the way it was 
handled by my experience, nor was it the experience of some 
that I heard of.
    In Natalie's case, years went by, hearings came and went, 
and adversity grew as Government experts came with several 
other possible alternate causes of death that did not agree, 
not even with one another. It seemed like any answer except 
vaccine was a possible cause of death and a reason to litigate 
further, because they could. Neither the circumstances nor the 
valid evidence nor the experts opinion that were paid for by 
the program were of any value in resolving that adversity and 
served at best only to keep the claim alive within that system.
    As more time passed, the more hearings, the more experts, 
the more adversity, the more inflation eroded both the 
resources to continue the claims and the original value of the 
awards, Government agents had the budget resources and could 
just run out the clock. In our case, we struggled to come up 
with the money rather than to lose the claim. At one point late 
in the process, we had to unexpectedly change expert witnesses 
due to problems unrelated to the claim. We had to sacrifice 
quickly and come up with retainer money for that replacement 
expert witness. We lost over $1,000 on the first retainer, 
money we were never able to recover.
    By that time we were single parents with split custody, and 
struggling with post-divorce finances. For both of us, it was a 
lot of money to fly and lodge separately in order to attend and 
testify in Boston, and later to attend the appeals court 
hearing here in Washington. Once the appeals court ruled, and 
mercifully there was not a further appeal, the judgment was 
paid within a reasonable time.
    By the end, I am sure Natalie's claim went well over the 
vaccine injury program's limit on both attorney costs and 
expert witness costs. I paid $10,000 from my portion of the 
judgment award for experts we used. I'm sure I paid only a 
portion of those expenses and none of the attorney firm's real 
costs. Yet when I asked, our attorney, Ron Homer, declined 
saying, ``you've been through enough, that money should belong 
to you and your family.''
    I feel all things combined created something other than 
what was intended in good faith by Congress. I doubt those 
disadvantages or disparities for claimants were due to any 
valid intent on the part of Congress; but they may suggest 
ongoing oversight.
    When an unexpected injury does occur, I can tell you from 
experience the last thing a family needs is a misguided lack of 
information or a complicated ordeal, compounded by adversity. 
What families do need is a reliable safety net. For my family, 
however, the outcome will not be happily ever after. I will 
always wonder the true effect Natalie's death had statistically 
or otherwise on our family.
    Not long after the vaccine injury claim was filed, 
Natalie's mother became despondent and expressed feelings of 
hopelessness. Unexpectedly, we separated. During the counseling 
that followed, she was diagnosed with depression. But in 
denial, she declined treatment. A domestic meltdown followed, 
with problems especially for the children. I'm old enough to 
know that there have been many factors in those matters. But in 
families, there can be complicated social side effects 
surrounding vaccine injury that have little to do with the 
original event, affecting entire families for a long time.
    We are urged by the origins of faith and morality to ``love 
our neighbor.'' In fact, we are told in Scripture that ``love 
is the law's fulfillment.'' I urge each of you to consider 
carefully and tenderly the lives of those who are touched by 
vaccine injury and this vaccine injury program.
    Again, I appreciate the opportunity to share this 
information with you. In my daughter's memory, I pray it 
contributes something useful and helps all of us somehow. Thank 
you.
    [The prepared statement of Mr. Sword follows:]
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    Mr. Burton. Thank you, Mr. Sword.
    Dr. Weldon, do you want to introduce Ms. Zuhlke?
    Dr. Weldon. Thank you, Mr. Chairman.
    I want to again welcome Janet Zuhlke for coming here. We're 
all looking forward to your testimony. I think it's very 
important, and I commend you for your willingness to come and 
provide the information about your experience with the vaccine 
injury program.
    Mr. Burton. Ms. Zuhlke.
    Ms. Zuhlke. Thank you, Mr. Chairman. Thank you, Congressman 
Weldon.
    I appreciate the opportunity to be here. My name is Janet 
Zuhlke. I was invited here today concerning my daughter, Rachel 
Anne. Rachel was adversely affected by her immunization at the 
age of 5. Rachel will be 17 this December. She suffers from 
seizures, mental retardation. I must bathe my daughter, take 
care of all of her personal needs, dress her, help her with 
feeding.
    Rachel was declared eligible for compensation in June of 
this year. We are now in the life care planning evaluation 
process. The circumstances surrounding her injury are basically 
the same. It was Thursday, March 1, 1990. Rachel again was 5 
years old. I had taken her to see her pediatrician, Dr. Richard 
O'Hern, as a well child, so that she could receive her DPT and 
OPV immunizations.
    Within 6 hours of her immunizations, she was displaying 
alarming symptoms that were unknown to me, specifically, 
vomiting and complaining of severe eye pain. Fever and soreness 
at the injectionsite were also present, but those were not 
unusual to me as a parent. Rachel is my middle child, I have an 
older daughter and a younger one as well. This was just 
different.
    On Friday, March 2nd, I phoned the doctor's office, 
expressing concern about the vomiting and the eye pain. I was 
told it was unrelated to the vaccines and to give the office a 
call on Monday if her symptoms had not subsided.
    Over the weekend, Rachel's vomiting had stopped, but she 
was still complaining of severe eye pain, and she had become 
lethargic, very abnormal for Rachel Anne. I was concerned with 
Rachel's lack of energy and the issue of the persistent eye 
pain, so much so that when the doctor's office opened on 
Monday, I was waiting at their door with my daughter.
    Rachel was seen by a nurse practitioner who diagnosed strep 
throat. There were no signs being exhibited of sore throat, 
runny nose, enlarged lymph nodes. She still had a low grade 
temperature. Again, a misdiagnosis.
    Over the next 20 days, Rachel became much more lethargic 
and complained continuously of eye pain. The severity of her 
condition became so apparent to me that I phoned Dr. O'Hern on 
that Sunday night, and he agreed to meet us in the emergency 
room at our local facility. Upon completing his examination of 
Rachel, he told me that something was affecting her central 
nervous system, that she would need to be admitted and tests 
would need to be performed.
    During that time, a barrage of questions came to me 
concerning could the child have ingested any household 
chemicals, pharmaceuticals, etc. It became more apparent in 
discussion with her pediatrician that the symptoms were the 
same as she presented on the March 5th visit, but with more 
acuteness. Rachel was air evacuated to Shand's Hospital at the 
University of Florida in critical condition.
    The way I learned about the NVIC program was through Dr. 
O'Hern. He apparently had checked with the drug manufacturers 
concerning the lot numbers on the serums that my daughter was 
given. He was told that there were no other reported cases. It 
was at that time that he informed me of the NVIC. Rachel's 
diagnosis then and to date has continued to maintain itself as 
post vaccine encephalitis.
    Filing the claim, I found an individual named Mr. Clifford 
Shoemaker out of Vienna, VA. I read an article in a newspaper 
by a family that had been affected as well. The mother was 
gracious enough to speak with me and give me this gentleman's 
name. Mr. Shoemaker has been representing Rachel since 1991, 
when her claim was filed.
    Although Rachel is eligible, she has not received any 
compensation for her injuries. All expenses have been out of 
pocket, from my family. And as you stated in your opening, sir, 
I am now going through receipts and trying to obtain this 
information so that I can be compensated for my out of pocket. 
In the first 5 years alone, and again, I'm almost going into my 
11th year now, I have documented bills showing over $25,000.
    Again, I was asked about observations regarding the 
effectiveness of this program. I also have great respect for 
immunizing your children. I still to this day think that is a 
very valuable thing that we must do. I have never fought 
through a drug manufacturer, nor have I had any sort of 
confrontation with Dr. O'Hern. I think he was doing his job. I 
think Rachel was given a drug that she should have been given, 
I just feel very badly that it turned out as tragically as it 
did.
    In addition to the regular medical exams, Rachel has had at 
least 30 medical emergencies which include numerous air 
evacuations and critical care. Every visit and incident that my 
daughter has undergone, I have had to provide to the Department 
of Justice information concerning those admissions. And as you 
can imagine, over time, she would have an episode, if you will, 
of one neurological dysfunction or another and we would get 
past that, I would submit that information and my child would 
neurologically fail again, and I then had to go back through 
and again provide information concerning that particular 
episode. It has been a never ending story.
    She still has problems. She still requires 
hospitalizations, and I still to this day am required to submit 
all medical records and information to the Department of 
Justice. It's time consuming and it is not cost effective. I 
have had issues where I have been in conversation with, I'll 
give an example of delays. Over the years there have been many, 
many deadlines given. I've been in status conferences with the 
special masters. Again, my daughter has had four.
    During one of these specific conferences, the Department of 
Justice was not prepared and they requested an extension of 
time. These extensions are not for days or even weeks. These 
extensions were for months at a time. I found that 
unacceptable. We could go 9 months easily without anything 
being done. And yet we'd come back to the status conference and 
again, the individual was allowed to have another deadline.
    I got so exasperated at one point, and again, I'm speaking 
to the special master, I didn't show much grace. I was very 
upset, I voiced my opinion, when is a deadline a deadline. I 
was not given an answer on that question.
    The ongoing impression I had and still have is that the 
Department of Justice made little effort to prepare for these 
deadlines. Since they were never challenged or commanded to do 
so, they knew the delay would be granted. There was never any 
sense of urgency and even after rescheduling, the DOJ often was 
still not prepared. Again, I find that unacceptable.
    I would like to say, of the four special masters, Rachel 
had one, the first was for 5 or 6 years. The next was for 2 to 
3. She's had two in the last 2 years. May I mention names, sir? 
It's Chief Special Master Golkowitz, actually, that was 
extremely helpful to my family. For the first time in many, 
many years, I felt like possibly seeing a light at the end of 
the tunnel. He was the gentleman you referred to before that 
had to recuse himself. He actually came to me after the very 
first hearing, which was supposed to be a mediation hearing, 
where the parties had come together on the assumption that we 
are going to agree.
    We went through the whole day, got finished, and the DOJ 
said, sorry, we offer you no settlement. He was incensed, to 
say the least. He found me in the lobby, you know what his 
words were, you repeated them before. He was ashamed. He was 
absolutely ashamed of how everything had transpired, and told 
me that he was sorry, but he was no longer impartial to be able 
to help me. He was no longer impartial.
    So we were passed on to a fourth special master who this 
gentleman is Master Hastings. Master Hastings has finally 
helped my family to a conclusion. And I'm very grateful.
    The adversarial aspects of this I think are just sad. I 
think Rachel has been treated basically like a criminal, like 
she's done something wrong, which is not the case. In spite of 
the early diagnosis that Rachel had experienced, severe central 
nervous system damage, specifically post vaccine encephalitis, 
the DOJ attorney repeatedly attempted to suggest alternative 
theories of the cause of her injuries. At one point, one of the 
experts for the DOJ actually stated that it must have been a 
virus that was in the community.
    In June 1999, Rachel's pediatrician, a doctor who has been 
with her since birth, gave a deposition. That same day, her 
pediatric neurologist also gave his deposition. Both physicians 
gave unequivocal testimony that it was their medical opinion 
that Rachel's injuries were directly caused by her vaccine. Yet 
in spite of that testimony, the DOJ attorney recommended to the 
third special master that the Government offer nothing.
    The adversarial process continues to this day. We are now 
in the life planning process. A life planner has come in for 
Rachel Anne. She has commenced the evaluation and the 
estimation of Rachel's lifetime care costs. The DOJ has 
appointed another life planner, who I have still not heard one 
word from. The young lady has come forward on Rachel's behalf 
to help. She's prepared, she's ready. I still haven't heard a 
word from the DOJ. I don't have an appointment time set up. I 
have nothing. And this is November 1st, and this process has 
been ongoing since July. Not even a phone call. Again, I find 
that unacceptable.
    The best evidence of the adversarial process, I think, is 
in the last line of the decision of the special master. He 
stated that Rachel's eligibility is ``a table injury 
encephalopathy.'' That is essentially the same diagnosis that 
was made 11 years ago by her pediatrician and ongoing 
immunologists and neurologists at Shand's Hospital.
    In my opinion, the DOJ's mission is to investigate crime, 
prosecute criminals and enforce the law. Litigation is their 
primary tool. The NVICP is based on a medical determination. I 
don't think the DOJ is the correct agency to make medical 
determinations.
    Based on my experience, I do not believe the program is 
working as Congress intended. I've read the proposed changes to 
the current law, and I very much support those proposed 
changes. In addition, I have three recommendations. I think a 
total time line for the entire eligibility determination 
process to be resolved, a fixed deadline, is needed. I think we 
need to redefine the goals for the process, ensure those goals 
include a sense of urgency and a total focus on making a 
compassionate medical decision.
    And again, as Harold was explaining, you've got to 
understand, it does not just affect the child. It affects the 
entire mechanics of your whole family. My 15 year marriage also 
fell apart from a unit that I thought was very strong. My other 
two children have suffered as well, not being able to do the 
things, possibly because of what their sister's needs were. And 
I, sir, have not taken a family vacation with my children in 11 
years, because there's not the money to do that. Because I have 
spent every dime on Rachel's medical needs. And again, to this 
day, have not received one penny in reimbursement.
    My third recommendation, and I'll be finished, I think you 
should create a regular independent oversight to ensure that 
the process is achieving the intent of providing a fair, 
expeditious and generous outcome to the families.
    Again, I appreciate the opportunity to be here and for the 
efforts that you are making for families like mine and for the 
other people that have graciously appeared today. Thank you.
    [The prepared statement of Ms. Zuhlke follows:]
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    Mr. Burton. Thank you. I want to thank all three of you. I 
know it's very difficult for you to be here and for you to 
testify about your family's problems. I can assure you that we 
will be overseeing the Justice Department on a regular basis as 
long as I'm the chairman. I don't know about my colleagues, but 
I will be talking to people at the Justice Department, 
including, when Mr. Ashcroft gets some time, with the tragedy 
that's going on here, facing the country, to discuss this as 
well.
    Let me start with you, Ms. Zuhlke. In his written 
testimony, which we have before us, and we'll hear from Mr. 
Harris in a little bit, Mr. Harris says that most of the people 
who complain about the program are people who lost their cases. 
He says, ``I believe it is the denial of scientifically 
unsupported petitions that may give rise to complaints about 
the program.''
    Did you win your case?
    Ms. Zuhlke. Yes, sir.
    Mr. Burton. How long did it take?
    Ms. Zuhlke. 10 years.
    Mr. Burton. You mentioned the complaints about the program, 
so I'll skip that. Have you talked to other families with 
similar complaints?
    Ms. Zuhlke. No, sir. I personally do not know other 
families with children who have been affected.
    Mr. Burton. Mr. Sword, did you win or lose your case?
    Mr. Sword. We finally won our case on appeal.
    Mr. Burton. So they fought you all the way through to the 
appeals process?
    Mr. Sword. Yes.
    Mr. Burton. How long did that take?
    Mr. Sword. We filed the claim when I discovered the 
information in the fall of 1990. And the final hearing for the 
appeals was in the spring of 1999, and we were paid in August 
1999.
    Mr. Burton. So it took over 9 years?
    Mr. Sword. Yes.
    Mr. Burton. What kind of complaints do you have about the 
program?
    Mr. Sword. I don't think it's compassionate enough. I think 
truthfully that the States need to be comfortable with 
mandating these vaccines. And I think that the public needs to 
be assured that the vaccines are both safe and if there is a 
rare reaction, that there is a mechanism there as a safety net 
for them to turn to.
    One other thing I would say is, I don't think there's 
enough information provided to families about either the 
dangers of vaccines, or I don't think there's enough provided 
about the options available to them when some kind of a 
question about a vaccine incident does occur. And I also think 
there's a problem with public records and the reporting that 
goes on in those areas.
    Mr. Burton. Have you talked to any other families that have 
similar complaints?
    Mr. Sword. I went to a vaccine conference here in 
Washington sponsored by the National Vaccine Information Center 
in, I think it was September 1997. I met many families at that 
conference. Since then, I've talked also with people in the 
State of Ohio, there is an advocacy organization in the State 
of Ohio, and I was asked to testify to the Ohio Legislature 
when they were considering mandating Hepatitis B. I told our 
story basically.
    And I met people that ranged from people with children to 
people that were adults. I heard a story about a volunteer 
fireman who was similarly affected and couldn't get a medical 
diagnosis. Many of these people are left in limbo. As I said in 
my testimony, I think many people either don't know or simply 
don't approach the program for a variety of different reasons.
    Mr. Burton. Mr. Rogers, I know the Government is now 
appealing your case. But when the special master made his 
decision last year, did you win or lose?
    Mr. Rogers. Won.
    Mr. Burton. You won?
    Mr. Rogers. Yes, sir.
    Mr. Burton. But the Government, the Justice Department, is 
appealing your case?
    Mr. Rogers. Yes, sir.
    Mr. Burton. How long did it take before you won initially?
    Mr. Rogers. Like I said, we started February 15, 1994.
    Mr. Burton. So it took almost 6 years?
    Mr. Rogers. Yes, sir.
    Mr. Burton. What kind of complaints would you have about 
the program?
    Mr. Rogers. Well, when we had heard about the program, I 
live next door to Auburn University. I went to their library, I 
call it the little green book, the one that Mr. Waxman had sort 
of designed. We read it from cover to cover. It sounded pretty 
interesting, especially the part like when you file it, and 
then a year after that, everything is taken care of.
    Well, this is not true, sir. It is not true at all. Even 
though my wife went through the table of the injury process 
with the tetanus shot, she fell in that table of what would 
happen if the vaccine was bad. But there's a lot of 
misinformation in that book that we just didn't understand. And 
like I say, it's just taking entirely too long. Like I say, 
they tell you when you file, it should be over within a year of 
the process.
    Mr. Burton. And it's taken 6 years?
    Mr. Rogers. Yes, sir. It's not.
    Mr. Burton. But the special master, and the initial 
decision was that she be compensated and you be compensated for 
her injury?
    Mr. Rogers. Yes, sir.
    Mr. Burton. And the Justice Department has appealed it?
    Mr. Rogers. Yes, sir.
    Mr. Burton. OK. I see that my time has expired. Mr. 
Tierney.
    Mr. Tierney. Thank you, Mr. Chairman. Thank you for having 
these hearings. I want to thank all of you for testifying. Any 
of us that have lost family know how difficult it is.
    I have to tell you, I am appalled at just thinking what 
you've been through in terms of time, whether your claim was 
ultimately rejected or allowed. The amount of time that you're 
talking about is just incomprehensible. I've done product 
liability cases in half the time of what you're talking about, 
the conclusion. So you have my sympathies on that. I look 
forward to later testimony and later hearings and then some 
legislation, perhaps, something that resolves even that aspect 
without getting into who's right or who's wrong. It's just 
beyond comprehension.
    Let me start from left to right if I could. Ms. Zuhlke, you 
had an attorney named Mr. Shoemaker?
    Ms. Zuhlke. That's correct.
    Mr. Tierney. Was he an experienced attorney in matters of 
this kind?
    Ms. Zuhlke. Apparently, he was. Again, I found an article 
in our local newspaper, a family that had been affected. I 
tracked them down and spoke with the mother who again provided 
me with information concerning Mr. Shoemaker.
    Mr. Tierney. He was aggressive on your behalf, he was a 
good advocate?
    Ms. Zuhlke. I believe so, yes, sir.
    Mr. Tierney. And you have no complaints about his 
performance?
    Ms. Zuhlke. No, sir, I don't.
    Mr. Tierney. And he didn't cause the delays of which you 
complained?
    Ms. Zuhlke. Not that I am aware of.
    Mr. Tierney. Mr. Rogers, did you have an attorney?
    Mr. Rogers. Yes, sir, I sure do.
    Mr. Tierney. And was he experienced in matters of this 
kind?
    Mr. Rogers. Very.
    Mr. Tierney. And did he cause any of the delays or problems 
that you had in getting attention to your claim?
    Mr. Rogers. No, sir. He wanted to get as much information 
as possible before he could really go before anybody. But the 
only problem with finding attorneys for this situation, to my 
understanding, this is like a specialized field, you just don't 
go to your local bar association. He did, and they said, they 
got the program, but they said, we can't handle anything like 
this, it's way above our head.
    So Mr. Ron Homer is my attorney from Boston. And we finally 
got in touch with him and said he has been dealing with this 
the last few years.
    Mr. Tierney. Well, if he's from Boston, I can tell you, 
he's probably a good guy. [Laughter.]
    Mr. Sword, you also had an attorney with some experience?
    Mr. Sword. Actually, I had a series of attorneys. I began 
with an attorney that I had a relationship with for a number of 
years in the community. They were part of a firm that is 
recognized as being one of the better law firms in the central 
part of Ohio. They did a referral to a firm in Chicago that had 
the case for, I don't know, maybe a year or two. There were 
some problems within that firm and the case ended up also in 
Ron Homer's firm in Boston when it was sent back to the firm in 
Columbus.
    And they located Ron Homer, and I can tell you without 
hesitation that is excellent representation. I would recommend 
him to anyone.
    Mr. Tierney. Have you been able to get any assistance in 
compensating your counsel during this period of time?
    Mr. Sword. Actually, the limits were the limits. As far as 
I know, I provided staff with a copy of a letter that was sent 
to me when we did settle that stated that the actual costs of 
the law firm was probably twice, over twice the allowable 
limit. They said it was over $60,000 and the cap was $30,000.
    So they lost a considerable amount of money on that case. 
In addition to that, we went well over the expense allowances, 
and I paid additional expense allowances out of awards as I 
agreed to before the case was actually resolved. I agreed to go 
ahead and do that.
    Mr. Tierney. In terms of your expert witnesses, am I right 
in assuming that all of you relied on your counsel to identify 
and engage expert witnesses on your behalf?
    Mr. Sword. I did.
    Mr. Tierney. Mr. Rogers, you did the same?
    Mr. Rogers. Yes, sir.
    Mr. Tierney. Ms. Zuhlke, of course you did the same?
    Ms. Zuhlke. Absolutely. I didn't know where to go.
    Mr. Tierney. Ms. Zuhlke, let me ask you something. I'm 
curious from your comments. You indicated that the last two 
masters that you had were good and you were happy to have their 
assistance.
    Ms. Zuhlke. Yes, sir, that's correct.
    Mr. Tierney. What did they do that made them better than 
the first two? What were the differences and why were you 
unhappy with the first two masters?
    Ms. Zuhlke. I think they moved things along, that was 
basically, I had a sense of, let's get going.
    Mr. Tierney. Progress?
    Ms. Zuhlke. Right. And I didn't have that, again, the first 
was John Edwards, who no longer is with the DOJ, I believe he's 
with HHS. Useless, basically, sir.
    Mr. Tierney. I think from your testimony it was pretty 
clear that you thought that they were getting continuances 
without making any particular showing for extraordinary need 
for more time?
    Ms. Zuhlke. That's correct.
    Mr. Tierney. Was that your experience, Mr. Rogers?
    Mr. Rogers. Well, in my wife's case, we had to have the 
phone conference deal with the special master, Government and 
our lawyer, everybody there. See, my wife is a registered 
pharmacist. She knows more, I'm not trying to be insulting, 
more than any physician in this whole country. She knows every 
drug, the whole nine yards, everything. And she just was 
sitting there laughing the whole time at the explanations they 
were giving of what was wrong with her, which didn't make any 
sense. The things that they were saying is not possible of what 
happened to her.
    Now, she's not a dummy, she understands every medical term, 
everything. Because a pharmacist is about as close to being a 
doctor as you can get. It was just comical the way they were 
trying to bullskate us with her problem. It just wasn't very 
professional.
    Another thing, the doctor that the Government had diagnosed 
her kind of like as having MS, which they treated her as, being 
she doesn't have it. I always thought a physician had to at 
least look at her or touch her to give a diagnosis. You don't 
give a diagnosis on the telephone. I mean, that's--even though 
he was giving his expert testimony, a physician should at least 
look at you, or at least meet you or something. You just don't 
do it over the telephone.
    Mr. Tierney. I want to thank all three of you. My time is 
up, but I do appreciate how difficult it was for you. We're 
very grateful that you came here today.
    Mr. Burton. Thank you, Mr. Tierney. We look forward to 
working with you on this.
    Dr. Weldon.
    Dr. Weldon. Thank you, Mr. Chairman.
    Janet, in your negotiations that are underway, will you be 
able to get any compensation for lost wages?
    Ms. Zuhlke. No, sir.
    Dr. Weldon. Can you give us some kind of an impression of 
how this tragedy has affected your ability to work, how much 
lost wages have you incurred? I know you've had a lot of out of 
pocket expenses. Can you give us a feeling for how much you've 
lost because you haven't been able to work?
    Ms. Zuhlke. Well, obviously, that would be in the 
thousands, sir. When Rachel Anne winds up in the hospital, it 
can be for 2 to 3 weeks at a time. And I am her primary 
caregiver. I do stay with the child. And again, I'm away from 
home. I've got to make arrangements for my other two children 
to either stay with family or friends.
    I did lose my job over this. I was a dental assistant with 
expanded duties. And I had worked for 15 years for a 
pedodontist, which is a children's dentist. And Dr. Vann had to 
let me go, understandably. I was unemployed for probably 
throughout 1990. It was just a hellatious year, just back to 
back issues for Rachel Anne. Then I went to work for my family, 
who showed me grace. And even on a Friday when I might not be 
there, because I was up at the hospital with Rachel, a check 
would be put into my account to cover my family's needs.
    My mother has cancer and my parents sold the business in 
November of this past year, a business that we had had for 23 
years. I went back into the dental field, I'm working as a 
surgical assistant now to a maxillofacial oral surgeon. And 
again, I'm working on a part-time basis.
    Rachel Anne is picked up at the end of my driveway by a 
special bus that takes her off to school and I have to make 
sure that she's taken care of. And again, I have no help. I 
don't have respite care or anybody else that comes in to help 
with meeting her needs. I've got to be there to get her off of 
the bus.
    Dr. Weldon. So when the settlement is finally reached, and 
you're in the negotiations phase for that, it will be for her 
care, you get nothing?
    Ms. Zuhlke. That's correct.
    Dr. Weldon. You said in the written testimony, I'm not sure 
if you mentioned this, that you had a life planner come in and 
the DOJ life planner has not contacted you yet?
    Ms. Zuhlke. That's correct.
    Dr. Weldon. But you made a very interesting statement in 
your written testimony. You said the DOJ life planner that's 
been assigned your case is ``known in the trade to be 
confrontational and to under-value costs.'' Can you explain to 
the committee how you were provided that information?
    Ms. Zuhlke. Yes.
    Dr. Weldon. And the nature of that information you 
received?
    Ms. Zuhlke. Yes, sir. The information came through Rachel's 
attorney. They have had to deal with this individual through 
the DOJ before. So they have past experiences with her. Also, 
the individual that has been employed now by myself, and again 
through Cliff Shoemaker, to come in as the life care planner on 
Rachel's behalf, gave me a heads up, so that I would have a 
clear understanding of what I was coming up against.
    And now it's the nickel and dime you to death. For every 
dime that Rachel's physicians will say to the life care planner 
will be necessary to meet my daughter's needs, apparently the 
DOJ side will come in and say, no, 2 cents is going to cover 
that. So now this is going to be another ongoing battle, is the 
way I perceive it. I have great faith in the people that have 
taken care of Rachel's needs at this point. I have no reason 
not to take them at their word on this level.
    Dr. Weldon. Were you advised by your counsel how long this 
process normally takes to come to an agreement? And does this 
have to go before the special master as well?
    Ms. Zuhlke. I was not given a timeframe, and yes, it does 
now again have to go back in front of a special master and 
another hearing.
    Dr. Weldon. And another hearing?
    Ms. Zuhlke. Correct.
    Dr. Weldon. You have no idea how long this will take?
    Ms. Zuhlke. No, sir. I anticipated at least a phone call by 
now, with at least scheduling some sort of a timeframe. Because 
again, I've got to organize Rachel's teachers, the guidance 
counselors have all of her IEPs, individual education plans, so 
they can track her course, make arrangements with her PCP so 
that his time is free, which I've already done that for Ms. 
Arnold.
    Dr. Weldon. PCP?
    Ms. Zuhlke. Primary care physician.
    Dr. Weldon. Would you explain to the members what that is?
    Ms. Zuhlke. I'm sorry. A PCP is a primary care physician.
    Dr. Weldon. So the doctor has to get involved with the life 
care planner?
    Ms. Zuhlke. Absolutely. Because he is her care giver. And 
he understands where she's been, where she's at and where she's 
going.
    Dr. Weldon. So you've already gone through this whole 
process with your life care planner, and now you have to go 
through this again with all the parties involved?
    Ms. Zuhlke. Yes, sir.
    Dr. Weldon. The pediatrician and everybody?
    Ms. Zuhlke. Yes, sir.
    Dr. Weldon. OK. I see that my time is expired, Mr. 
Chairman.
    Mr. Burton. We'll stay with this panel for a while, if you 
have additional questions.
    Mr. Duncan.
    Mr. Duncan. Thank you, Mr. Chairman.
    Let me first of all say that my wife and I have four 
children, and I think anyone who's ever had children at least 
greatly sympathizes with each of you and what you've been 
through. I can also tell you, I think it's almost criminal, or 
should be, that you've been put through all these years of 
having to deal with the bureaucratic delays and so forth.
    I know there are exceptions to almost everything, but you 
know, State courts, despite having much heavier workloads, 
usually conclude cases in about half the time on average that 
the Federal Government does. And you know, we see all the time 
that the least efficient way to handle anything is to have the 
Federal Government handle it. But I think it's very sad that 
people are put through years and years and years of dealing 
with this program.
    I think you all should know, too, that most Federal judges 
and most Federal hearing officers and special masters almost 
always rule in favor of the Government, because that's usually 
the easiest way to deal with things. So you have won big 
victories, I think, in having rulings in your favor.
    But you know, thinking back to when my children were small, 
we got all these vaccines, and I had never heard anything about 
these problems. I think that almost all parents, I would say 
99.9 percent of parents, don't know about these things and are 
convinced that they're doing something good for their children. 
And I know that it must be especially hard for you all to take, 
what happened to you, because I'm sure that you thought you 
were doing what you should have been doing for your children to 
make them healthier.
    Do you all think that enough is being done now to ensure 
these vaccines are safe? Do you have an opinion about that? 
Have you read research, anything about that? Mr. Sword.
    Mr. Sword. Well, as I commented in my testimony, there was 
about 30 years between the time of the first reports of the 
twin deaths in the mid-1940's and the time that my daughter 
died of vaccine injury. My understanding is, there have been 
many, many deaths since then. It was my understanding that, I 
believe it was an acellular vaccine was developed for pertussis 
in the early 1980's, perhaps in Japan. I may stand corrected if 
I have that information wrong. But it was not available in this 
country for a considerable amount of time, and then it was only 
available as an option.
    So I don't think there is enough research, and I don't 
think there is enough really known about the problems with 
vaccine injury and the experience. Because it just simply isn't 
well reported.
    Mr. Duncan. I think the overwhelming majority of the 
American people don't even know that this program exists today. 
And I wonder, I've seen where there have been 6,000 claims 
filed. I wonder how many thousands of others there are that 
have been told that it was not the vaccine or they didn't 
figure it out. Do you all think that's happened or that there 
are a lot of people who don't know about this? What do you say 
about that, Ms. Zuhlke?
    Ms. Zuhlke. I think that's factual. I think people aren't 
aware of it. I didn't know anything about it until Rachel's 
pediatrician put me onto this path. And again, I have three 
children. I must say that I heard Mr. Sword's comments before, 
my children now are past the immunization aspect. So I'm 
probably not as informed as I should be in helping other 
people.
    I am aware of the fact that at Dr. O'Hern's office, 
Rachel's physician, everybody that comes in with a child is 
required to read this full booklet that gives all symptoms, 
side effects, adverse reactions, and they must initial each 
page, that they have understood clearly what could happen to 
their child. That information is then documented and put into 
each child's chart. I think that is extremely helpful.
    Mr. Duncan. Mr. Sword.
    Mr. Sword. My suspicion is that this may very well begin in 
the medical training process, both for doctors and nurses, and 
that it may very well be that there is not enough sensitivity 
on the part of the medical community and the training process 
to adequately ensure that either the medical providers or the 
patients are adequately informed in an appropriate way. Not so 
as to scare people, but to treat them with the care that they 
really need and to provide to them the information and caution 
that's necessary in order to prevent a lot of these things from 
going well beyond where they might otherwise go.
    Mr. Duncan. Finally, let me just mention, we're going to 
hear on the next panel a witness who will say that the Justice 
Department handles these cases in a cooperative and non-
adversarial fashion, and that they're much more cooperative 
than other similar types of cases. I take it none of you have 
found that to be true, is that correct?
    Ms. Zuhlke. That's correct. And I'd like to be on that 
panel instead of this one.
    Mr. Duncan. Do you think that some of these companies, that 
there's some big money behind some of these companies that 
produce these vaccines? I mean, so often what we find in these 
things is the money that's behind it, in other words, they 
convince the medical establishment that something is good 
because they're making huge profits out of it.
    Do you think that enters in at all? Or why do you think 
they say the companies are getting out of the vaccine business 
now, the childhood vaccine business? Have you looked into that 
at all? Mr. Sword.
    Mr. Sword. I have not looked into that. But I always had 
the feeling from the people that I came in contact with, and 
from the attorneys that I came in contact with that there was a 
giant standing in the shadows of this whole thing, and that 
that giant had a lot of influence. On the other side of that, 
you have children, you have a variety of different kinds of 
people that are mandated as a condition of employment to take 
these vaccines. You have policemen, firemen, doctors, nurses 
and so forth who are all, so you have this balance here. And 
the Government has to in some way sort that out.
    But quite frankly, I just don't think that the absence of 
some kind of oversight because of the presence of these vaccine 
manufacturers, the possibility of revolving door, and as the 
chairman stated in his opening statement, the conflicts at the 
Government agencies, that there could ever be a resolution to 
this without some kind of ongoing congressional oversight to 
this.
    Mr. Duncan. Thank you very much, Mr. Chairman.
    Mr. Burton. Thank you, Judge.
    Let me ask you a question, Mr. Sword. You said that 
initially somebody said your daughter died of SIDS?
    Mr. Sword. That's correct. And that was a common diagnosis 
of cause of death, as my understanding was. There were a lot of 
these cases that were misdiagnosed from the very beginning as 
being SIDS.
    Mr. Burton. We have known throughout the country that there 
were a lot of children that died from SIDS and there's been 
some concern that those may not have been just normal ways for 
children to die, but that they were as a result of vaccines 
that were given to the children. I think we ought to take a 
look at that and see if we can find any statistical data to 
find out when children who die with SIDS got vaccinations and 
the proximity of that time to their death, just to have some 
statistical data. So can we check into that?
    Let me ask you a couple of questions, Ms. Zuhlke. In his 
written statement, Mr. Harris, who will be on the next panel, 
says the Justice Department lawyers are cooperative and non-
adversarial. I know you've answered this a little bit. He says 
the Justice Department undertakes its responsibilities in a 
more cooperative manner than would be expected from defendants 
in civil litigation. He also says, I do not believe that the 
manner in which the VICP cases are processed has become more 
adversarial. In fact, I believe it's quite to the contrary.
    And would you once more tell me, each one of you, what you 
think about that statement?
    Ms. Zuhlke. Well, sir, I don't think I can really tell you 
what I think about that statement, but I don't think it's 
factual.
    Mr. Burton. I think you just did.
    Ms. Zuhlke. OK, sir.
    Mr. Burton. Mr. Rogers.
    Mr. Rogers. Well, this whole situation is really hard to 
understand. But I really wish my wife could have come and you 
could really hear it from the horse's mouth. Because it's 
really hard to interpret everything she's going through.
    And one thing, I don't really think the public really knows 
about this. They just take stuff for granted. I just think a 
lot of people are getting the runaround on this. We're just not 
getting anything professional out of it.
    Mr. Burton. We'll try to make sure the public knows more 
about it.
    Mr. Sword.
    Mr. Sword. I guess it's depending on how you define 
cooperative and how you define non-adversarial and so forth and 
so on. In my case, I thought it was rather adversarial, to a 
fault. Other cases that I've heard of, similar kinds of things, 
I've heard statistics that somewhere around the area of two-
thirds of the claims were rejected for pertussis deaths.
    So I think on the whole, there may be some effort on the 
Government's part to do that. But I don't think they're doing 
nearly enough, if they are, and they should make a better 
effort in good faith.
    Mr. Burton. Ms. Zuhlke, did you ever observe a special 
master lose his temper or lose his patience with a Justice 
Department lawyer?
    Ms. Zuhlke. Yes, sir.
    Mr. Burton. What happened? Tell me what happened.
    Ms. Zuhlke. That was in the second hearing.
    Mr. Burton. What did he say?
    Ms. Zuhlke. I'm sorry, sir, I cannot give it to you 
verbatim at this point. But some comments were made, and 
special master did get a little incensed over it. One thing 
that does stick in my mind is, at the end of that particular 
hearing, and again this is the second hearing, the attorney for 
the DOJ said, ``oh, by the way, there is a piece of evidence 
that we don't have.'' And it turns out this piece of evidence 
he had desired, he'd known about for 9 years. And now at the 
end, literally the end, the closure of that hearing, I also 
lost my temper.
    Mr. Burton. He asked for evidence that had been known for 9 
years?
    Ms. Zuhlke. Yes, sir, and he said parts of it were not 
available, it had to do with slides of my daughter's brain 
tissue, because she's had two open brain biopsies. And he was 
stating that part of that material had never been received. And 
the special master wanted to know, well, what took you so long 
to come up and say something. Now is a very inappropriate time 
and you may not continue with trying to obtain that. And the 
hearing was closed.
    Mr. Burton. I'd like to maybe, if you can give us the name 
of that attorney, I'd like to check on that.
    Ms. Zuhlke. Yes, sir.
    Mr. Burton. Mr. Sword, did you find the Justice Department 
to be cooperative and non-adversarial in your case?
    Mr. Sword. I didn't feel that they were cooperative. I felt 
that it was, they came with three different causes of death 
that didn't agree with one another. We got into the hearing in 
Boston and they had an expert there who kept nodding out in the 
first part of the proceedings.
    As she proceeded into her testimony, this woman kind of led 
to a fantasy testimony, that if there had been the technology 
at the time of Natalie's death that existed now, she could have 
made a different diagnosis. And I don't know how you deal with 
that kind of a fantasy when you're talking about facts and when 
you're talking about what was available in the records and so 
forth.
    I kind of sat back in my chair and I started to listen to 
this, and quite frankly, it upset me so bad that I had to leave 
the room. I left the room.
    Mr. Burton. So you don't think she had the expertise 
necessary to actually make comments?
    Mr. Sword. I think some of these people come in there, and 
they make their living doing adverse testimony, quite frankly.
    Mr. Burton. How about you, Mr. Rogers?
    Mr. Rogers. Well, I know they've got their job to do, but 
it's----
    Mr. Burton. Well, you were in meetings with these people. 
What kind of response did you have in the meetings?
    Mr. Rogers. Well, we just did not understand what they were 
going after. I mean, I know my wife being an adult, which is 
totally different than a child having this problem, they kept 
going back to things that had happened to her years prior to 
anything. Like she had vertigo at one time, they said, well, if 
you have a tetanus shot and you have vertigo, you're going to 
have MS and blah, blah, blah, which is not really true.
    With her expertise as far as medicine, she just didn't 
believe half the stuff they were telling us. But the special 
master, evidently she's got a lot of medical knowledge, because 
she knew exactly what was going on. But she was supposed to 
have been the deciding factor in all this.
    Mr. Burton. My time's just about up. Did you think that the 
Government was trying to disprove your case? They weren't 
trying to work with you? Were they working with you or were 
they trying to disprove your case?
    Mr. Rogers. I really believe they were just trying to 
disprove it. They just didn't believe it was true.
    Mr. Burton. How about you, Mr. Sword?
    Mr. Sword. I don't think there was any question that was 
what was at the core of what motivated them. They were 
attempting as desperately as they could to disprove that case.
    Mr. Burton. Ms. Zuhlke.
    Ms. Zuhlke. Same exact thing. That's exactly my words. That 
works for me.
    Mr. Burton. Mr. Tierney, do you have any questions?
    Mr. Tierney. No, thank you. They've been through enough. 
Thank you.
    Mr. Burton. I think that suffices. If you have any 
additional comments you'd like to make to the committee, we'd 
like to have those. We're going to have, when we come back from 
votes, we've got a series of votes, we're going to have the 
other panel from the Justice Department and HHS. If you'd like 
to stay around, we might solicit some comments from you at the 
conclusion of their remarks.
    And with that, we stand in recess until the fall of the 
gavel, which should be in just a few minutes after the final 
vote. I think have two or three votes. So it will probably be 
half an hour before we get back.
    [Recess.]
    Mr. Burton. I again call the committee to order.
    We'll now hear testimony from the second witness panel. 
Thomas Balbier and John Euler, would you please approach the 
committee table? Oh, Mr. Harris, excuse me. Mr. Harris.
    [Witnesses sworn.]
    Mr. Burton. Which one of you replaces Mr. Euler? I guess 
Mr. Harris does.
    Do you have opening statements? We'll start with you, Mr. 
Balbier.

   STATEMENTS OF THOMAS E. BALBIER, JR., DIRECTOR, NATIONAL 
 VACCINE INJURY COMPENSATION PROGRAM, ACCOMPANIED BY GEOFFREY 
EVANS, MEDICAL DIRECTOR, AND DAVID BENOR, OFFICE OF THE GENERAL 
    COUNSEL; AND PAUL CLINTON HARRIS, SR., DEPUTY ASSISTANT 
  ATTORNEY GENERAL, CIVIL DIVISION, U.S. DEPARTMENT OF JUSTICE

    Mr. Balbier. Good afternoon, Mr. Burton.
    Mr. Chairman and members of the committee, I'm very pleased 
to be here this morning to talk to you about the National 
Vaccine Injury Compensation Program. The National Vaccine 
Injury Compensation Program 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 quickly, while still 
preserving their rights to file suit in the tort system.
    The program significantly reduces, but cannot eliminate, 
the tension and adversity inherent with any litigation process 
for resolving claims. I heard members discuss earlier this 
morning that I would be coming here and talking about a system 
that was non-adversarial. You will not hear me say that. I've 
been saying for years that the system is designed to be less 
adversarial than the tort system that people otherwise would 
have to go through. And it is.
    I was asked specifically to address three major issues in 
my testimony this morning. They are complaints that the statute 
of limitations is too narrow and excludes families from the 
program, complaints that the inability to make interim payments 
to petitioners places them at a disadvantage, and complaints 
that the program has, in general, become too litigious and 
adversarial.
    We have attempted to address these issues through a wide 
variety of methods. In June 1999, a draft bill entitled the 
``Vaccine Injury Compensation Program Amendments of 1999'' was 
sent to Congress. This proposed bill contains specific 
legislative proposals that addressed each one of these issues 
noted above.
    I also heard earlier a recommendation that there should be 
an independent group to provide oversight for the compensation 
program. That group exists. Those recommendations came from 
that group. We developed the proposals based on recommendations 
from the Advisory Commission on Childhood Vaccines, comprised 
of medical professionals with expertise in pediatrics, 
attorneys, including those representing families filing claims 
under the program, and equally important, parents of children 
injured by very rare, but serious adverse reactions to 
childhood vaccines.
    One of these proposals would extend the current statute of 
limitations from 3 years for injury claims and 2 years for 
death claims to 6 years for those claiming injury or death 
resulting from a covered vaccine. Another proposal would permit 
the interim payment of litigation costs after a determination 
that the petitioner is entitled to compensation. Another would 
allow compensation for family counseling and costs to families 
related to establishing a guardianship or a conservatorship.
    Other proposed legislative changes would address the 
rulemaking process for changes to the vaccine injury table. 
Currently, the process for changing the table requires a period 
of 180 days for public comment, including the opportunity for a 
public hearing. During the last public hearing for proposed 
changes to the table, no member of the public attended the 
hearing. Decreasing the length of time for public comment and 
eliminating the mandate for a public hearing will enable the 
program to make needed changes including the addition of 
injuries to the vaccine injury table in a more efficient 
manner.
    The administration supports these proposals. The statute of 
limitations is extended, potentially enabling more families to 
seek compensation. Also, the proposal recognizes and attempts 
to ease some of the financial burdens of petitioners. It is 
critical to remember that although the program is far less 
adversarial than the tort system, which it was designed to 
replace, it was established for a very specific group of 
intended beneficiaries.
    The program encourages anyone who believes they have a 
condition caused or significantly aggravated by childhood 
vaccine to file a petition for compensation. Petitioners' 
rights, as you heard, are vigorously advocated by their 
attorneys, who are paid reasonable attorney fees and costs, 
regardless of whether petitioners are compensated, so long as 
there is a reasonable basis for the claim and it is brought in 
good faith.
    However, the program was never intended to serve as a 
compensation source for a wide range of naturally occurring 
illnesses and conditions, which unfortunately affect many of 
our children.
    I also was asked to discuss changes to the vaccine injury 
table. We have amended the table twice so far, in 1995 and 
1997. I spoke extensively to those changes when I testified 
before in front of this committee. We've now begun the process 
of making further changes to the vaccine injury table. The most 
important of these changes is to add intussusception, the 
telescoping of the intestine, as an injury associated with the 
rotavirus vaccine. Rotavirus is a childhood vaccine licensed by 
the Food and Drug Administration in August 1998. A series of 
reports to the Vaccine Adverse Event Reporting System found 
that some infants developed intussusception after receiving the 
vaccine. The VAERS system, as we call it, is a signaling system 
that has been set up to monitor adverse events. The Centers for 
Disease Control and Prevention, based on this signal that we 
received from the VAERS system, then recommended that health 
care providers and parents postpone the use of rotavirus 
vaccine while we looked into this further. Shortly thereafter, 
the manufacturer voluntarily withdrew the vaccine from the 
market. After consulting with our Advisory Commission on 
Childhood Vaccines, we published a notice in the Federal 
Register on July 13th of this year. The notice would add 
intussusception as a table injury using criteria based on 
scientific data currently used by HHS and the Department of 
Justice for recommendations to the court on compensation. 
Already, four claims of intussusception associated with the 
rotavirus have been compensated.
    In addition, we have taken steps to ensure that potential 
claimants are notified about their ability to file a claim with 
the program. We have developed a press release which was 
distributed on July 25th. We participated in a conference call 
with State and territorial health officials, asking them to 
notify all who had reported intussusception following rotavirus 
immunization, and we sent a followup letter also. We've been 
publicizing this change on our Web site and through our 
outreach efforts.
    All indications are that the program is working very much 
as intended by Congress. The process of determining whether, 
and at what level, compensation should be awarded will always 
involve conflicting opinions and a natural tension. There will 
always be program areas that can be improved, and we continue 
to try 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 ensure that 
varied interests of families, health care professionals, 
attorneys and the vaccine industry are represented in a regular 
public forum. The Advisory Commission on Childhood Vaccines, 
with its widely diverse membership, brings good balance and 
perspective and has been instrumental in identifying program 
improvements that have consensus support.
    The ACCV was established by the act, and I quote from the 
act, to ``advise the Secretary (of HHS) on the implementation 
of the program.'' That's very broad oversight responsibility. 
The 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, also as 
required by statute, and has made numerous legislative and 
administrative recommendations over the years aimed at 
improving the operation of the program.
    The ACCV developed and approved legislative proposals that 
I mentioned previously. The Department remains committed to 
making this program and to making ongoing improvements to the 
program, so that children and families 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'll be pleased to answer any additional questions you 
may have. Thank you.
    [The prepared statement of Mr. Balbier follows:]
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    Mr. Burton. Mr. Harris.
    Mr. Harris. Good afternoon, Chairman Burton and members of 
the committee. I'd like to thank you for this opportunity to 
appear before you this afternoon on behalf of the 
administration.
    So that I may limit my remarks, I request that my full 
written statement and our views letter to you, Mr. Chairman, 
dated October 17th, be entered into the record.
    In the early 1980's, Congress faced a looming public health 
crisis concerning injury from immunizations which involved 
complex, fiercely debated medical issues overlaid with the 
emotion of personal loss and tragedy in individual cases. I've 
sat through the prior panel, and we've heard testimony to this 
effect this morning.
    In order to stabilize our Nation's supply of vaccines and 
promote our universal vaccination policy to combat childhood 
disease, Congress established the Vaccine Injury Compensation 
Program. Petitioners are afforded under this program a more 
streamlined system of recovery with free counsel provided in 
each case, in which their meaningful participation in the 
process is assured.
    This supply of life saving vaccines is protected and a 
safer, better system of vaccines is currently being developed. 
Vaccines have improved the lives of millions of Americans. This 
program has been a cornerstone of the Nation's ability to 
achieve these important objectives. The Justice Department's 
role is to implement the statute and to uphold the provisions 
of the act.
    By design, this is a program rooted in science. Congress 
set forth specific eligibility criteria based on the most 
current and accurate scientific evidence available. We at the 
Justice Department ensure that fair compensation is provided to 
those who meet the eligibility criteria determined by Congress 
and that the vaccine injury trust fund is protected against 
claims that do not meet this standard.
    Over the past 5 years, approximately half of all cases have 
been compensated. The use of alternative dispute resolution has 
increased threefold in the last 2 years. We have initiated 
efforts to further expedite case processing by organizing a 
group of special masters, members of petitioners' bar, parents 
and HHS staff to review and revise the court's guidelines for 
practice.
    We have supported many legislative proposals that will 
benefit petitioners, such as an extension of the statute of 
limitations, and payment of interim litigation costs, as 
described in greater detail in our letter to the chairman. We 
rarely, rarely appeal cases to the Court of Federal Claims, and 
even less frequently to the Court of Appeals for the Federal 
Circuit.
    Of the 5,400 cases resolved since 1988, 109 cases have been 
appealed to the Federal Circuit. The Government has appealed 
only 13 of those cases. Most significantly, since 1993, we've 
appealed only one case to the Federal Circuit, and that was 3 
years ago, in 1998.
    In consideration of all this, I simply cannot agree with 
any suggestion or accusation that the program has become more 
litigious. It simply has not. Rather, I think it has become 
less so. The language of the act calls for a less adversarial, 
expeditious and informal proceeding. The Justice Department has 
gone to great lengths to fulfill this congressional objective.
    We collaborate with the court and opposing counsel in 
developing creative and novel approaches to resolving each 
claim. As such, the Justice Department has developed a 
cooperative atmosphere to move cases along. Our initiatives 
have contributed to promoting an atmosphere of cooperation 
among all parties involved.
    Admittedly, some cases are prolonged or drawn out for 
various reasons. And you've heard stories again from families 
today that illustrate such cases. Resolution of cases simply 
cannot always be accomplished as quickly as we would prefer. 
There exists an obvious tension between efficiency and the 
important principle of due process.
    The issues can be difficult and complex. For example, in 
the entitlement phase, the concept of causality can be 
difficult to prove, as the Institute of Medicine recognizes, 
not the Justice Department. The arousal of one's suspicion that 
a vaccine might be the cause of an adverse event that occurs 
within hours, days or weeks following the receipt of the 
vaccine is natural and understandable. But the mere fact that B 
follows A does not mean that A caused B.
    It is for this reason that the act requires scientific 
evidence that the injury is related to the vaccine, and forbids 
payment of compensation based on the claims of a petitioner 
alone. We cannot ignore the statutory criteria or the consensus 
of the scientific community on medical causation issues.
    With regard to determining compensation to be awarded, 
Congress has set forth a detailed list of categories of 
compensable items. The amount sought is frequently in excess of 
several million dollars. While often time consuming, the key is 
that the program process is far more thoughtful and tailored as 
compared with other alternatives. The goal is no less than 
establishing a custom tailored plan of lifetime medical care, 
and in as many as 90 percent of the cases, this is an issue 
settled by the parties.
    In short, I firmly believe that 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. The debate and the 
emotion in these cases will never be eliminated, 
understandably. But an efficient mechanism is in place to 
address these difficult issues. To date, almost 1,700 families 
have been compensated nearly $1.3 billion. This is an 
outstanding measure of this program's success. The truth is 
that these families would have stood little if any chance of 
obtaining any relief in the traditional tort system.
    Mr. Chairman, members of the committee, I thank you again 
for this opportunity and I'll be pleased to answer your 
questions.
    [The prepared statement of Mr. Harris follows:]
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    Mr. Burton. How many cases have been filed?
    Mr. Harris. In the life of the program, there have been 
roughly 6,000 cases filed.
    Mr. Burton. And how many did you settle?
    Mr. Harris. 5,400 have been adjudicated, and how many have 
been settled, I couldn't give you that number.
    Mr. Burton. I think you just gave a figure there of 1,000 
something, wasn't it?
    Mr. Harris. We have paid compensation to 1,700 families.
    Mr. Burton. So less than a third have received 
compensation.
    Mr. Harris. In the early part of the program, clearly, 
less, there was a tendency not to pay petitioners. But that 
percentage has gone up, Mr. Chairman.
    Mr. Burton. Ah. But there was a tendency not to pay.
    Mr. Harris. Yes. And we worked closely with your----
    Mr. Burton. How long have you been doing this, Mr. Harris?
    Mr. Harris. How long have I been on the job, sir?
    Mr. Burton. Yes.
    Mr. Harris. Since July of this year, sir.
    Mr. Burton. Well, where did you get all this expertise? 
It's kind of amazing that you have all the answers so quickly, 
and you've just done it since July?
    Mr. Harris. Yes, sir. I do my homework.
    Mr. Burton. Oh, OK. That's very good. I appreciate the 
opening statements, but what I didn't hear was any meaningful 
discussion of what we heard this morning. What do you think 
about the three families that were here this morning?
    Mr. Harris. Well----
    Mr. Burton. I mean, obviously you've only been on the job 3 
or 4 months.
    Mr. Harris. Clearly.
    Mr. Burton. So maybe you didn't study these three cases, 
but they've been going on from 6 to 10 years.
    Mr. Harris. Actually, I have studied those.
    Mr. Burton. Well, then, why were they paid, if there was no 
merit to their case?
    Mr. Harris. Two of the cases, as you recognized, Mr. 
Chairman and members of the committee, are cases that are still 
pending and----
    Mr. Burton. Why are they pending?
    Mr. Harris. I cannot comment on specific circumstances of 
open cases.
    Mr. Burton. But they're being appealed, right?
    Mr. Harris. Two of the cases this morning are being 
appealed, that's correct.
    Mr. Burton. For a layman like myself, tell me, a special 
master says they should be paid, right?
    Mr. Harris. Correct. In certain cases.
    Mr. Burton. Yes. And then if the Justice Department doesn't 
agree, then they appeal it?
    Mr. Harris. Correct.
    Mr. Burton. I see.
    Mr. Harris. Rarely. Very rarely do we appeal.
    Mr. Burton. Well, we had two of those cases this morning, 
did we not?
    Mr. Harris. That's correct. Which is why what we heard this 
morning, as emotionally tragic as those cases are, they're not 
a representative sample of what we deal with. Let me throw out 
some numbers. 300----
    Mr. Burton. Let me just interrupt you real quickly. You say 
they're not representative of what you deal with, and yet you 
said there's been over 6,000 cases filed and you gave 
compensation to less than a third of that. Now, the thing 
that's interesting is, and I'll be happy to bring you and Mr. 
Balbier back here every week or every month if you like and 
bring three or four more people in and have them testify again 
and again and again about the shortcomings of the system. I'll 
be very happy to do that if you guys want to spend the rest of 
your life before my committee. I don't have any problem with 
that.
    But I see no reason to do that, because we had three 
examples this morning. What I can't understand is, why these 
people have been judged to be in compliance with the statute 
and should be paid, one of them is being compensated, and the 
other two, the special master agreed, one of them I think had 
three or four special masters, but it has been agreed, and yet 
the Justice Department decides to appeal the case.
    Mr. Harris. Mr. Burton, I'd like to answer the question 
about appeals. Because one might get the impression that our 
tendency is to appeal. And that is not the case.
    Of the 335 cases that have been appealed to the Court of 
Federal Claims in the history of the program, for entitlement 
or damages issues, the Department has only appealed 57 times. 
All the other appeals have been by petitioner. It's important 
to know that.
    Mr. Burton. What happened on those 57 cases?
    Mr. Harris. What happened in each case?
    Mr. Burton. I mean, how many were settled in favor of the 
Justice Department and how many were not?
    Mr. Harris. I'd be happy to get that information for you.
    Mr. Burton. Well, wait a minute. You said you've been 
studying this issue. Fifty-seven cases have been appealed and 
you don't know how many you guys won or lost?
    Mr. Harris. We have that information but I'm not a 
statistician and I can't spit out every----
    Mr. Burton. But that's very important.
    Mr. Harris. It is important, and I'd be happy to get that 
information.
    Mr. Burton. Because if the Justice Department is appealing 
these cases and you're not winning, it may be an indication 
that some of these, the special master may know what they're 
doing. And they may be cases that shouldn't be dragged out for 
months and years while these people suffer.
    Let me ask a few questions here. Ms. Zuhlke, she didn't 
lose her case. Mr. Sword didn't lose his case. Mr. Rogers 
hasn't lost his case. Do you think that those complaints that 
you heard this morning were just sour grapes?
    Mr. Harris. Well, I would respectfully have to say that a 
characterization that they haven't lost the case would be 
unfair, because the cases are still pending. And I do not think 
it's sour grapes. I think it's horrible what has happened to 
these families, and the problem in each of these cases, given 
the complexities of the medical and scientific issues involved, 
overlaid with the emotion, is that no matter how efficient our 
process is, and respectful of due process rights, given the 
fact that there is collateral repercussions to the injuries 
that are involved, you heard breakup of families, that no 
matter how much we compensate these cases, people are going to 
be dissatisfied.
    Mr. Burton. Let's go through the process. We have a special 
master that's appointed by the court, right?
    Mr. Harris. Correct.
    Mr. Burton. And the special master goes into all the 
details, looks at the medical evidence, listens to the 
testimony and everything else, and the special master makes a 
decision, is that correct, after studying the issue, and 
hearing all the testimony?
    Mr. Harris. That would be correct, sir.
    Mr. Burton. OK. So the special master makes a decision. In 
several of those cases, they had more than one special master. 
And you heard the outcomes. The special masters in all three 
cases agreed that compensation should be paid. You in two cases 
have decided to appeal those cases. And those cases have been 
going on from 6 to 10 years.
    Mr. Harris. Right. And the answer to your question is, 
there are occasions where we do not agree with the special 
master. But there are rarely occasions we don't agree with the 
special master that we feel so strongly to take these cases on 
appeal. In the last 4 years, we've only taken six cases on 
appeal. There are currently about 700 cases pending. So any 
impression that we are just willy-nilly taking cases to appeal 
in an overzealous litigious fashion would be unfair.
    Mr. Burton. Excuse me, now, Ms. Zuhlke's case is not being 
appealed. And the Sword case was appealed but you lost. So two 
of the three----
    Mr. Harris. Correct.
    Mr. Burton [continuing]. Have been appealed, but they've 
been settled. So the third one is the only one that's on appeal 
now, right?
    Mr. Harris. I said two were appealed, correct.
    Mr. Burton. Two were appealed but you lost one of them, 
right?
    Mr. Harris. One of the cases is still pending. One we lost, 
the Sword case is a closed case.
    Mr. Burton. You lost.
    Mr. Harris. Correct. We appealed that case from the special 
master to the Court of Federal Claims.
    Mr. Burton. Does it bother you when you appeal a case like 
that and you lose? Does it bother you that you dragged a case 
on for 6 or 8 years? And when Congress passed this, you know, 
you stated the intent of Congress, I was here. I was one of the 
people that was involved in the decisionmaking process to pass 
that legislation. And it was our intent to make this much less 
adversarial for people who had to go through the trauma of 
having a child or a sibling or a wife or husband injured. And 
that's why we got the drug companies off the hook, so they 
wouldn't be sued and have endless litigation, so they could 
produce these pharmaceutical supplies.
    So the intention of Congress, as I recall, because I was 
here, and you've only been there 3 or 4 months, was that we 
make this very, a lot less adversarial. As I said, I'll be 
happy to bring before this committee as many people as you 
want. I could bring maybe 50, 100 people at different times to 
tell you about situations like we heard this morning.
    So for you to give the impression to this committee and to 
the Congress that there's not a lot of problems out there, 
there are a lot of problems. And we haven't brought the 
attorneys before the committee who have handled these cases. 
The thing about the attorneys is, they're limited, I think it 
is, to $30,000?
    Mr. Harris. That is incorrect.
    Mr. Burton. How much are they limited to? Is there any 
limit?
    Mr. Harris. They're limited in retrospective cases. But if 
the cases are not retrospective, meaning the injuries are post-
act cases, there is no limit.
    Mr. Burton. Well, we had the one case, we heard about a 
while ago, where the attorney worked for almost 10 years and 
was given $30,000.
    Mr. Harris. Mr. Sword's case.
    Mr. Burton. Yes.
    Mr. Harris. That was a retrospective case.
    Mr. Burton. Well, I understand. But the point is, if you're 
trying to get a counsel, a legal counsel, to take on a case 
like this, and they have to spend 5, 6, 7, 8 years trying to 
get the case resolved, a retrospective case like you're talking 
about, there aren't many attorneys that are going to do that, 
because they're not going to do it on a pro bono basis, that 
means no cost basis. They're going to want a fee. And $30,000 
for 10 years on a retrospective case is nothing.
    Mr. Harris. Mr. Chairman, I couldn't agree more. But 
unfortunately, we have to abide by what the act tells us we 
have to abide by.
    Mr. Burton. Ah.
    Mr. Balbier. Mr. Burton, I might add that the deadline for 
filing retrospective claims expired more than 10 years ago. So 
the cap on attorney fees in cases has not been a problem at all 
for the program for well over 10 years. That only applies to 
the vast majority of claims that were filed for injuries that 
occurred prior to 1988, when the program went into effect.
    Mr. Burton. Let me get back to that. My time has expired 
and Dr. Weldon's been very patient as well as Mrs. Davis, so 
I'll let them have some time.
    Dr. Weldon.
    Dr. Weldon. Thank you, Mr. Chairman.
    Can either of you gentlemen tell me if you'll be sending 
somebody down to do the life care plan on Janet Zuhlke's 
daughter, Rachel? She's been waiting since July. Is that 
handled by your office, Mr. Balbier, or you, Mr. Harris?
    Mr. Harris. I think the policy typically is we don't assign 
a life care plan provider until we've received the life care 
plan from the petitioner.
    Dr. Weldon. She has sent it to you. In light of the fact 
that her case has been going on for 12 years, can you get 
somebody down there before Thanksgiving?
    Mr. Harris. Thom, do you want to----
    Mr. Balbier. Representative Weldon, one of the initiatives 
that came out of our advisory commission was the idea that we 
could develop life care plans using one life care planner for 
both parties. That is for both the petitioner who has filed a 
claim, and the Government who has to implement the statute.
    In the cases where we've been able to use what we call a 
joint life care planner, that has tremendously helped the 
resolution of the case. And we've been using them for many 
years.
    However, that's at the beginning of the damages process. If 
the family and their attorney agrees with the concept of using 
one life care planner, it goes very, very quickly.
    Dr. Weldon. Well, we heard testimony from her, she's lost a 
job, she can't work, she's had tremendous out of pocket 
expenses, it's been going on for 12 years, she hasn't heard a 
word since July. I'm just asking you a simple question, can you 
ask somebody in your office to call her and set up an 
appointment to get the life care planner down there? You can't 
answer that question? Why not?
    Mr. Burton. Are you asking that question of Mr. Balbier?
    Dr. Weldon. Yes.
    Mr. Balbier. I'd like to answer that, actually. It does 
seem like a very simple question. The honest answer is, there 
may be a life care planner on the way right now. I honestly 
don't know. No, I can't answer that question. But we can find 
out.
    Dr. Weldon. Who makes the decision? Who decides when 
somebody goes down to Florida and--cat got your tongue? You're 
looking at me like--whose office? Is it Justice or is the 
vaccine program?
    Mr. Balbier. While the damages negotiations are underway. 
The Department of Justice trial attorneys handle most of that. 
We offer assistance wherever possible. And again, there would 
be no need for a life care planner to go down there had we been 
able to go with just one. That really helps resolve cases 
quickly. And we've had many cases resolved that way.
    Dr. Weldon. So you're saying you may accept the plan that 
she submits rather than send another person down and negotiate 
the plan?
    Mr. Balbier. Mr. Weldon, what I'm saying is that----
    Dr. Weldon. The reason you're not responding to me, is it 
because this is all in negotiations? Is that----
    Mr. Balbier. Well, as you know, with any case that's under 
litigation, you can never comment on negotiations. This is 
litigation. We try to make it a less adversarial process.
    Dr. Weldon. Let me just ask you a very bland question. Can 
you try to expedite this case in the months ahead? Is there a 
place in your heart to find a willingness to expedite this 
case?
    Mr. Balbier. We try to expedite every case. When I first 
saw, and it was just yesterday, which witnesses would be here 
testifying, which families, I recognized the names. I 
recognized them, although I didn't know immediately why. When I 
looked into it, I remembered that the Zuhlke's case was one of 
the lengthiest proceedings in the history of the compensation 
program.
    The facts in the Sword case stand out, when you first see 
them, you think, why would the Government ever appeal this 
case. And then when I heard of the other witness, that name was 
also familiar, Rogers. That was familiar most recently, because 
Congressman Burton asked me about that case.
    Dr. Weldon. Let me ask you another question. She has----
    Mr. Harris. I may be able to help you out here, if you'd 
like.
    Dr. Weldon. OK, go ahead. If you can make it quick.
    Mr. Harris. Yes. I did not come prepared to discuss 
specific details of the Zuhlke case, but I can assure you that 
I will have one of our attorneys contact her attorney by 
tomorrow. And I'll be happy to get back with you on that.
    Dr. Weldon. I would like another assurance from you, that 
you will not seek any retribution against this lady and her 
family based on the testimony she has provided here.
    Mr. Harris. Let me make clear, the Justice Department never 
seeks retribution. In fact, we find it offensive for folks to 
characterize honest Federal Government employees as seeking 
retribution against U.S. citizens who have suffered such a 
loss, and we wouldn't do that.
    Dr. Weldon. Mr. Harris----
    Mr. Harris. We have never done that and there is no 
evidence to support that.
    Dr. Weldon. You draw your employees from the ranks of the 
human race. And you may be a very, very nice person, as may be 
Mr. Balbier. But as we all know, dealing with every Federal 
agency, there are occasionally some people who will do things 
like that. So I would just ask that you would take some 
personal interest in this matter to make sure personally that 
nothing of that nature happens.
    Mr. Harris. I will take a personal interest in this matter, 
and I can assure you that in any instance where there is an 
allegation that our attorneys are acting in any untoward 
fashion----
    Dr. Weldon. I'm not saying there's any allegation. I'm 
just, I'm a little concerned, because she has said some things 
here that a lot of people would be afraid to say.
    Mr. Harris. I understand that, and I'm sensitive to that, 
and I'll look into it and make sure that her attorneys are 
contacted. But I have to reiterate, there is no tendency on the 
Justice Department officials to seek retribution against 
citizens. If you have evidence into that, I'd love to have it.
    Dr. Weldon. No, I don't have any evidence of that. I'm just 
being cautious. Thank you.
    Mr. Burton. I'll be glad to talk to you about a few cases 
after we adjourn, because there has been some cases of what I 
would consider retribution I think you probably ought to be 
aware of.
    The other thing I'd like to say before I yield to Ms. Davis 
is this. You're going to respond to Ms. Zuhlke's problem by 
calling tomorrow. What about the other people that we can bring 
in, and I'm sure that there's probably over 100 or maybe more, 
that would require the same kind of attention that haven't 
received it? Should we give you a list of those so that you can 
respond to those quickly?
    Mr. Harris. Mr. Chairman, if you have a list of folks that 
we haven't contacted in months, I'd love to have a list of 
those folks.
    Mr. Burton. Well, you're going to get it.
    Mr. Harris. I appreciate that.
    Mr. Burton. I will have that for you. And since you've been 
on the job a short time, I think that maybe you are going to be 
able to make a difference, and I'll get you that list.
    Mrs. Davis.
    Mrs. Davis of Virginia. Thank you, Mr. Chairman.
    Mr. Harris, I know you've only been on the job since July. 
Mr. Balbier, how long have you been involved in this?
    Mr. Balbier. For a little over 11 years, I've been the 
Director of the program.
    Mrs. Davis of Virginia. So you're pretty familiar with all 
three of these cases, then.
    Mr. Balbier. No, I'm not. I was familiar with the 
histories. The names were familiar when I first heard of them. 
And again, that was only just yesterday when I saw the witness 
list.
    Mrs. Davis of Virginia. But you made a comment a minute ago 
that based on the facts, you had to wonder why the Justice 
Department appealed, I think it was Mr. Sword's, is who you 
said.
    Mr. Balbier. Well----
    Mrs. Davis of Virginia. That was the one, if I'm not 
mistaken----
    Mr. Balbier. That wasn't----
    Mrs. Davis of Virginia. Let me finish. That was the one, if 
I'm not mistaken, that they just said that it was appealed and 
it was lost. So who makes the decision to appeal? Does HHS 
recommend it or does DOJ look at it and make the determination? 
Who makes that determination?
    Mr. Balbier. That's an excellent question. We make the 
determination together. However, it's really up to the 
Department of Health and Human Services. We are the ones who 
are responsible for administering this program. Our 
pediatricians are the initial reviewers of cases after they're 
filed. They make recommendations to the court. They first 
prepare a medical report.
    And then in cases where we concede they've met the criteria 
of the statute, we move immediately to damages negotiations. 
And we've had cases resolved in as little as 97 days. But in 
cases where they don't meet the criteria of the statute, that's 
where problems arise. People, honest, reasonable people, good 
families, have very different opinions on injuries that are 
surrounding the administration of vaccines, and whether they 
seemingly are caused by vaccines.
    And as I said, with the Zuhlke case, I remember that case 
years ago when we first got a congressional inquiry on that 
case. And that was my reaction, why did we appeal that case? It 
wasn't fresh in my memory.
    Mrs. Davis of Virginia. The Zuhlke case or the Sword case?
    Mr. Balbier. No, the Zuhlke case.
    Mrs. Davis of Virginia. But did you not say a minute ago 
when you were talking that on the face of it, you didn't 
understand why the Sword case was appealed. I believe that's 
what you said.
    Mr. Balbier. OK, I'm trying to remember what the----
    Mrs. Davis of Virginia. Mr. Sword. The one that was 
appealed and was won.
    Mr. Balbier. It's the Sword case, you're right. It's the 
Sword case I'm thinking of, that's correct.
    Mrs. Davis of Virginia. It was appealed, and you lost when 
you appealed it.
    So I guess my question is, I'm assuming then that HHS 
recommended to DOJ----
    Mr. Balbier. That's exactly how it works.
    Mrs. Davis of Virginia [continuing]. To appeal. But you're 
with HHS.
    Mr. Balbier. That's right.
    Mrs. Davis of Virginia. You just said that when you looked 
at the facts of the case, you had to wonder why it was 
appealed.
    Mr. Balbier. I raised the question, why did we appeal. I 
looked into it and I had a very good answer to that question. 
My staff filled me in.
    Mrs. Davis of Virginia. I'd like to hear it.
    Mr. Balbier. I'd like to be able to tell you that.
    Mrs. Davis of Virginia. OK.
    Mr. Balbier. That case is in litigation and I can't.
    Mrs. Davis of Virginia. I thought you just said it was 
lost.
    Mr. Balbier. That case is still in litigation.
    Mrs. Davis of Virginia. Did you not just say that the 
Sword's appeal was lost?
    Mr. Balbier. As far as we're concerned, all these cases are 
in litigation. And we cannot discuss them.
    Mrs. Davis of Virginia. Mr. Chairman, I'm sort of confused 
here.
    Mr. Balbier. If the gentlelady would yield, as I understand 
it, they're in litigation not on the outcome but on the amount 
of compensation, is that correct?
    Mr. Balbier. As I said, I cannot discuss these cases, 
they're on appeal. I can't discuss what the issues are in these 
cases.
    Mrs. Davis of Virginia. But I believe----
    Mr. Burton. Excuse me. The Sword case you can't discuss, 
even though that's been completed?
    Mr. Balbier. The case actually has not been completed. I 
don't believe that case has been paid, has it?
    Mr. Burton. The money's been paid, has it not?
    Dr. Weldon. The Sword case is a closed case, Mr. Chairman.
    Mr. Burton. And you can't comment on that, Mr. Balbier? You 
can't comment on the Sword case?
    Mr. Balbier. I did not come here prepared to comment on the 
Sword case, specifics of that case. As I said, I didn't know 
that----
    Mr. Burton. Well, I want you to know that you guys are 
going to be up here more than you ever dreamed you were going 
to be up here if you don't cooperate with this committee. And 
hiding behind a case that you say is ongoing and you can run it 
on for 8 or 10 years is not going to be acceptable. Now, I hope 
you get used to looking at me, because you're going to be up 
here a lot. And if you don't want to come, I'll subpoena you. 
And if I have to go to Tommy Thompson and have him bring you up 
here, I'll do it. This is ridiculous.
    The gentlelady's time--I'm sorry.
    Mrs. Davis of Virginia. That's OK, Mr. Chairman. I guess 
what concerns me, Mr. Balbier, is you're sitting here stating 
that you cannot comment on a case, yet you yourself without 
being asked the question commented on the case a minute ago 
when Representative Weldon was speaking. You said that when you 
looked at that case, you couldn't understand why it was 
appealed.
    Mr. Balbier. That is correct.
    Mrs. Davis of Virginia. Then you answered the chairman that 
the appeal had been lost. So I guess I've got a real problem as 
to why you make a comment that you don't understand why you 
appealed it----
    Mr. Balbier. I got----
    Mrs. Davis of Virginia [continuing]. You just answered me 
that HHS makes the----
    Mr. Balbier. I was simply confused between the two cases.
    Mrs. Davis of Virginia. Well, if you've got your memory 
back now, can you tell me why you appealed it?
    Mr. Balbier. I didn't come here prepared to discuss the 
merits of that case.
    Mr. Harris. I might be able to help.
    Mr. Balbier. I don't have the specifics in front of me. We 
can, if you would like, we can provide for the record the case 
history of that case and why it was appealed. And the issues 
involved. They are complex.
    Mr. Harris. I'd like to be able to help answer some of your 
questions, if you would permit me to do so.
    Mrs. Davis of Virginia. That would be fine.
    Mr. Harris. Just to clear up where we are with the three 
cases that we heard from this morning, the Sword case, to my 
understanding, if I recall correctly, is a closed case and 
payment was made on that case, I believe, in August 1999. 
There's one case pending on damages, which is the Zuhlke case, 
and there's another, the Rogers case is pending on appeal. So 
if you have questions about the Sword case, I think I'd feel 
comfortable in answering those questions.
    If your question is, why was that case appealed, it was 
appealed because we disagreed with the theory used by the 
special master in determining that case, because it was a 
theory that was not discussed in the litigation process. 
Because it was not discussed in the litigation process, we did 
not have our opportunity to present our side of her theory.
    Once the special master made a decision, we tried to 
introduce evidence that would in effect present our side of 
what her theory turned out to be. She decided not to hear that, 
we appealed to the Court of Federal Claims. The Court of 
Federal Claims agreed with the special master, and we decided 
not to take it any further. So that's where that case ended.
    I think it would be safe to say that because of the appeals 
taken in the Sword case it was protracted out over months. 
However, once the decision was made by the Court of Federal 
Claims in June 1999, payment was made to the family by August 
of that year.
    Mrs. Davis of Virginia. Thank you, Mr. Harris.
    I don't know if it's appropriate to make this comment, Mr. 
Chairman, but I'm going to, and you can call me down if I'm 
incorrect. I can understand, Mr. Balbier, why the petitioners 
feel an adversarial role from the Government, because I felt an 
adversarial role from you when you responded to me.
    Thank you, Mr. Chairman.
    Mr. Balbier. I apologize if you felt that way. That was not 
my intent.
    Mr. Burton. Mr. Platts, I'm sorry, I didn't see you. Do you 
have any questions?
    Mr. Platts. Actually just one to followup, Mr. Chairman.
    Mrs. Davis, it sounded like, Mr. Balbier, that you have an 
answer. I understand you didn't come prepared to get into 
specifics. But it sounded like you have an answer to the 
question about the appeal when you asked and you looked at it 
and you were given an answer, but you didn't think you could 
share it, because that was a pending case. Now that we have 
resolved that is a closed case, the answer that you apparently 
wanted to give but thought you couldn't, it seems like you can 
now give.
    So I'd be interested in hearing that answer.
    Mr. Balbier. I think in the Sword case the medical issues 
were very complex. I had them explained to me very late last 
night by my medical staff. And I understood them at the time, 
and I understood why we appealed the case and I understand that 
there was confusion, or misinterpretation of the findings of 
the medical experts in those cases. And we decided to appeal 
that case based on the interpretation of the statute by the 
special master.
    Mr. Platts. Thank you, Mr. Chairman.
    Dr. Weldon [assuming Chair]. The Chair now yields to 
himself 5 minutes for a second round of questions.
    Mr. Balbier, you said in your testimony that you have done 
a lot to let people know about the program. Have you done a 
study or a poll to see what is the level of awareness on the 
part of the public of the vaccine compensation program? 
Specifically, parents of newborns.
    Mr. Balbier. We have not done any studies to date to do 
that.
    Dr. Weldon. I would recommend you do so. Because one of the 
themes I've heard over and over again is that people hadn't 
heard about the program. I think we would be well served to get 
some sort of measure, objective measure of what the level of 
awareness is. It may help us in the Congress to work with your 
agency to raise the level of public awareness.
    I also want to say to you that I appreciate the endorsement 
of many of the provisions of the legislation introduced by 
Congressman Nadler of New York and myself, H.R. 1287. Would you 
be willing to commit to sit down with my staff or members of 
your staff with my staff to see if we can work out acceptable 
language to the administration on some of these reforms that 
both Congressman Nadler and you and I would like to see moved 
forward on?
    Mr. Balbier. We'd be happy to do that.
    Dr. Weldon. Thank you. I will have my staff set up a time 
for that. I personally believe we should be able to pass these 
reforms in a bipartisan fashion.
    Mr. Harris, as I understand it, if a family retains an 
attorney and puts in a claim, it goes before the program and 
the program has pediatricians, basically, that analyze the 
merits of the case, and if the decision is made by the vaccine 
program managers to deny compensation, it's turned over to you 
and then you oppose settlement. And if these cases go before 
the special master, you actually have the ability to bring in 
experts, is that correct?
    Mr. Harris. That's correct.
    Dr. Weldon. OK.
    Mr. Harris. And petitioners, I might add, have that as 
well. One of the problems that petitioners face, once they pass 
the eligibility phase, or the fact that they are eligible for 
the program, is the expense involved in hiring experts. And 
we're sensitive to that. If your bill proposes to provide some 
fees to help in that, that would be something that we would 
certainly support.
    Dr. Weldon. OK. That was the kind of answer I was hoping to 
get. That's a complaint I've heard over and over again, that 
some of these attorneys are big-hearted enough to just wait and 
wait and wait years and years to get their payments. But it's 
impossible for them to be paying out for these experts.
    I was very, very disturbed in reviewing the case of Ms. 
Zuhlke, these repeated delays from DOJ. No explanation at some 
of these hearings why they were asking for continuance. Some of 
these continuances going on as long as 9 months is what my 
constituent complained to me. The impression I get, just from 
listening to her, I'm reading between the lines here, it was 
often just the case, the attorneys were not prepared.
    I don't believe that is acceptable at all. You said you 
took this job in July. What did you do prior to July?
    Mr. Harris. I practiced law, and I was also a State 
legislator in the great Commonwealth of Virginia.
    Dr. Weldon. Wonderful. I think we've met before, haven't 
we?
    Mr. Harris. I don't think so.
    Dr. Weldon. Quite all right. You didn't practice 
specifically medical malpractice or medical defense, did you?
    Mr. Harris. No, Congressman. My practice was primarily 
labor and employment law, although I'm familiar with medical 
malpractice issues.
    Dr. Weldon. OK.
    Mr. Harris. I would add that, I would hope that I'd have, 
and I think I do, a Congressman who is as interested in 
representing their constituents as obviously you are for Ms. 
Zuhlke. I would find it unacceptable for a lengthy, 
unnecessary, unsubstantiated delays in cases, and I want to 
assure you that I will look into that.
    I also think the point that you made about making sure that 
parents are aware of this program is a very good point. For our 
part, our attorneys and HHS officials, we regularly attend 
conferences, both in the legal community, and medical 
community, to try to make sure that information about the 
program gets out to the general public. We distribute packets 
with information in it.
    This year, we attended 11 such conferences, and certainly 
hope to improve on that number next year. But your point about 
making sure that families who are not aware of this program 
become aware of it is a well taken point. To the extent we can 
help with that kind of outreach, we welcome that opportunity.
    Dr. Weldon. Well, the reason I was asking you about your 
background is, maybe as you were made aware earlier, I'm a 
physician. I practiced medicine for 15 years before I was 
elected to the House of Representatives. I happen to know the 
pediatrician pretty well who takes care of her daughter. He's a 
Duke graduate, he's a really smart guy. And when she first 
brought her case to me, I actually read the chart.
    And you screwed up, basically, in my opinion, on this case. 
Unless you've got information that you're not revealing, 
dragging this one on for 12 years is really bad. It makes the 
program look bad, it makes the Congress look bad. And I would 
highly encourage you to come to an expeditious resolution of 
this case. I'm certainly looking forward to working with you in 
the weeks and months ahead, in crafting ways that we can try to 
improve the program so that it better meets the needs and 
intent of Congress.
    There's universal agreement that it's too adversarial. I 
understand your comments, Mr. Balbier, that the way we wrote 
the law, it's still adversarial. And I accept the 
responsibility for us to make it less adversarial.
    I also recognize the importance that it be based on good, 
quality medical science. Excuse me 1 second.
    Today we have heard that some of the special masters' 
handling of the compensation cases were frustrated, and/or 
angry about Justice Department conduct. They made comments like 
embarrassed, they called prosecutors abrasive, tenacious and 
obstreperous. They called arguments egregious. Obviously you 
can see why we are concerned.
    Mr. Harris, do you agree with these observations?
    Mr. Harris. No. I think that our attorneys do the best job 
they can. They act professionally, they act with compassion in 
these programs. But they also have a professional 
responsibility to abide by the standard and the criteria set by 
Congress, which is a preponderance of the evidence standard, 
which means that basically, the case that the petitioners 
present only has to tilt just the slightest bit in their favor, 
in which compensation awards are paid.
    I know that the remarks that you made there from the 
special master pertaining to one of our attorneys was, I 
believe, made in the Marks case. And I would have to put those 
remarks into some kind of a context, look into the case and I'd 
be happy, again, to get back with you with what we discover. 
But as a rule or something that happens very infrequently, of 
course not. Every----
    Dr. Weldon. Well, when comments are made like that by a 
special master, it reflects very, very poorly on the Justice 
Department. I would hope that you would take appropriate action 
in your new position to make sure that you do not have 
attorneys working for you that would engage in practices that 
would precipitate those kinds of comments by a special master.
    Mr. Harris. I certainly will do all I can to make sure that 
kind of conduct obviously does not take place within the 
Department. I feel very comfortable at this point in saying 
that it doesn't. I believe that, I mean, you have to put 
comments into perspective. That same special master who derided 
our attorney was described as worthless in the prior panel.
    Dr. Weldon. Well, I appreciate your sharing that. And I 
know the special masters are drawn from the human race as well. 
But the comments made in the Mann case are not unique. There 
have been other similar types of complaints.
    I'd like to now yield to the chairman of the committee, the 
gentleman from Indiana, Mr. Burton.
    Mr. Burton [resuming Chair]. Thank you very much, Dr. 
Weldon.
    I just had a couple of followups on this question. It says, 
when you have those kinds of comments made in a hearing where 
the special master says that they're embarrassed, they call the 
prosecutors abrasive, tenacious, obstreperous, do you guys 
agree with those comments that they made?
    Mr. Harris. I don't agree with those comments, no.
    Mr. Burton. Well, you're pretty new. Do you agree with 
these comments?
    Mr. Balbier. I don't know the context in which those 
comments were made, Mr. Burton. But I've known most of the 
trial attorneys at DOJ for quite a long time. There are some 
newer attorneys, but most of them have been with the program 
for quite some time. And certainly my experience has been just 
the opposite.
    The attorneys come before our advisory commission, too, and 
have worked with the commission. The advisory commission has 
had the opportunity to meet several of the trial attorneys at 
the Department of Justice over the years. They've been more 
than cooperative, and I think represent us quite well before 
the courts. If we had any concerns about the quality of 
representation, we would have made those concerns known with 
the Department of Justice. But we've never had any problems at 
all.
    Mr. Burton. When a special master makes comments like 
those, do they have any place to go? Is there any review 
process? I mean, if they're talking to somebody over there at 
your Department or Justice Department and they feel like 
they've been meeting with people who are arrogant or 
obstreperous or abusive, where do they go?
    Mr. Harris. Certainly when a special master makes those 
kinds of comments with respect to a Justice Department lawyer, 
we review it, as we did in this case.
    Mr. Burton. Who reviews it?
    Mr. Harris. The director of the department that oversees 
the vaccine program, and if necessary, I'll review it myself. 
But I can tell you that the special master has recently 
appointed this particular attorney who is the subject of these 
derisive comments to be chairman of the process group to work 
very closely with the special masters.
    Mr. Burton. Well, that sounds like a step in the right 
direction.
    Mr. Harris. A quality individual.
    Mr. Burton. How does the VICP select expert witnesses? Do 
you require them to disclose financial ties, either personal or 
institutional, with vaccine manufacturers or other Government 
agencies, such as NIH? And that's very important, because we 
have been, I have subpoenaed the financial records of a lot of 
people that are on advisory committees over at HHS and so 
forth, and we have found some people who are on these advisory 
committees who are making recommendations on vaccines and so 
forth that have conflicts of interest.
    In other words, one of the fellow on the rotavirus, one of 
the people on the advisory panel that Mr. Balbier referred to 
regarding the rotavirus vaccine, he was the chairman of that 
committee and he had a lot of stock in one of the companies 
that made the rotavirus vaccines. And what you didn't mention 
was that although the company withdrew the Rotashield from the 
market, it was because there had been so many adverse reactions 
and it was less than 1 year after it had been put on the 
market, No. 1.
    And No. 2, there were several people on the advisory panel 
that had real reservations about that vaccine ever being put 
into the marketplace in the first place. Nevertheless, the 
chairman of that committee had financial ties to a 
pharmaceutical company and it was put on the market. One child 
died and several others had severe problems.
    So we'd like to ask the same kind of question. Do you 
require these people who are expert witnesses, do you require 
them to disclose financial ties, either personal or 
institutional, with some of these vaccine manufacturers?
    Mr. Balbier. Let me try to answer that question, because 
you asked about the expert witnesses who testify and also about 
the advisory commission members.
    Mr. Burton. Well, I didn't ask about the advisory 
commission members, because I already know. I've checked. I've 
subpoenaed and got their financial records. They didn't want to 
tell me that, like you didn't want to tell us some things, so I 
sent a subpoena out and I got the records. We have found, and 
there are financial records, a lot of them were incomplete, 
which we're still checking on, we have found that they had 
financial ties to pharmaceutical companies, and we think that 
might have tainted their judgment just a bit.
    Nevertheless, we're talking about these expert witnesses 
right now.
    Mr. Balbier. No, we don't require that they fill out any 
conflict of interest forms at all.
    Mr. Burton. Why wouldn't you think that might taint their 
judgment just a little bit? Let's say, for instance, I'll give 
you an example, let's say that a person had strong interest in 
a pharmaceutical company that manufactured a product. And that 
product was the one that we suspected caused an adverse event 
in a child who was vaccinated. Would you think that person 
would be an unbiased witness?
    Mr. Balbier. I would think that something like that 
probably would come up in court, or it could come up in court 
proceedings.
    Mr. Burton. Not unless somebody asked. I mean, your 
advisory panels over at HHS, nobody ever asked many of those 
people, they got a financial disclosure statement and many of 
those were completely vacant. There wasn't anything on it until 
we checked.
    So an expert witness that's testifying, it seems to me 
logical the first question asked is, do you have any financial 
ties to the company that manufactured the product that created 
this adverse event. Seems like you'd want to ask that, wouldn't 
you? Wouldn't you?
    Mr. Balbier. Quite honestly, it hasn't come up.
    Mr. Burton. I know it, that's why I'm bringing it up now.
    Mr. Balbier. Right. I'll have to look into that and let you 
know. I honestly don't know. I'm not aware that we require 
that. I don't think that we do.
    Mr. Burton. Well, I will make a suggestion that you do 
require it. Because anybody that has a bias, pro or con, on a 
subject like that, it should be made public. And if they do 
have a bias, let's say, in favor of a pharmaceutical company 
that may have been sued, now they're not going to be sued 
because of the compensation fund, but if you have a company 
that may have a financial interest in that product, it seems to 
me logical you'd want to know that before you made that person 
an expert witness.
    Mr. Harris. I would be happy to work with your staff, Mr. 
Chairman, if that's something that you feel strongly about, 
which apparently you do, to see what we can do to do that. From 
my own view, if I were an expert influenced by a drug company, 
I think my tendency would be to tell the folks to pay out in 
every case so that I wouldn't be sued in State court.
    Mr. Burton. Well, I really ought to show you these advisory 
committee panel financial statements we have. Because what we 
found out was that people, and particularly on the Rotashield 
vaccine, the chairman of that committee had stock in the 
committee that was manufacturing one of those vaccinations. And 
he strongly supported it going into the marketplace.
    You would think that he would have thought twice about 
that, wouldn't you? But he didn't.
    In 1993, the Institute of Medicine published a report, 
Adverse Events Associated With Childhood Vaccines. Evidence 
bearing in causality recommended that research be conducted to 
answer the following question: Is the age at which the vaccine 
is given a factor in adverse events experienced? Are some 
groups of individuals more predisposed to experiencing such 
adverse events than others? Are there common denominators among 
individuals who have reported vaccine injuries to VAERS or 
filed claims through the VICP?
    What is the extent to which vaccines can trigger disorders 
through immune reaction? Are there long latency adverse events 
following vaccinations? Long term studies and biologically 
plausible late onset adverse events? Use of newly devised 
laboratory tools for virus detection to determine vaccines that 
have been historically accepted as safe to detect additional 
viruses?
    After this report was published in 1993, what actions did 
your office take in communicating with other HHS agencies such 
as CDC and NIH to request these research activities take place? 
I think we'll address that to you, Mr. Balbier.
    Mr. Balbier. Yes, Mr. Burton. We don't conduct any 
research, scientific research, in our program or for that 
matter, really in our agency. Research is conducted primarily 
by NIH, CDC, and of course, the licensing of vaccines is the 
responsibility of FDA.
    Mr. Burton. Let me interrupt you here. What I'm asking is, 
this report was published, which would have a direct bearing on 
a decision that might be made regarding an adverse reaction. So 
it seems to me these questions would have to be answered in 
order for you to make an intelligent decision on an adverse 
reaction. And so what I'm asking is, after this report was 
published in 1993, did your office take any action to say to 
these other agencies, HHS, CDC and NIH, did you say, hey, have 
you guys done any research in these areas? Because all of these 
would have a bearing on whether or not the adverse reaction was 
as a result of the vaccination. And if you didn't do that, I 
want to know why not.
    Mr. Balbier. All right. There has been quite a bit of 
research done on adverse events related to vaccines. CDC can 
discuss that in much better detail than I can. But what I can 
tell you is what we have done. One of those----
    Mr. Burton. Did you request answers to those questions I 
just gave you?
    Mr. Balbier. Well, in the one instance that affects our 
program, and that----
    Mr. Burton. These all affect your program.
    Mr. Balbier. No, I mean----
    Mr. Burton. All of these questions I just read, every 
single one of them would have an impact on the decisionmaking 
process on whether or not an adverse event was one that should 
be compensated. And if you have not asked these agencies if 
they have done these things and what the results of those 
studies were, then you don't have the answers.
    Mr. Balbier. No, we work very closely with those agencies 
and we are----
    Mr. Burton. Let me read those to you again. This is 
important.
    Is the age at which the vaccine is given a factor in 
adverse events experienced? I'm going to give you this so you 
can take it with you, because I don't think you have these 
answers. Are some groups of individuals more predisposed to 
experiencing such adverse events than others? And have they 
done any checking on that? Are there common denominators among 
individuals who have reported vaccine injuries to VAERS or 
filed claims through the VICP?
    What is the extent to which vaccines can trigger disorders 
through immune reaction? Are there long latency adverse events 
following vaccinations? Can it be over a longer period of time? 
Do they lay dormant in somebody? We're talking right now about 
anthrax. There's some question about whether or not there's a 
latency period before these anthrax onsets take place. So 
that's something we ought to know.
    Long term studies and biologically plausible late onset 
adverse events? Use of newly devised laboratory tools for virus 
detection to determine vaccines that have been historically 
accepted as safe to detect whether or not they're not safe?
    So I'm going to give you this. Those are things that need 
to be looked into before a decision is made.
    I want to say one more thing, and I see all my colleagues 
are gone, so I'm the only one left, so I'm not going to keep 
you here any longer than necessary. I have one more question I 
was asked by one of the families that testified.
    The lawyers for the Justice Department that are taking on a 
case that's appealed, they're paid every week, aren't they? Or 
do you get paid every month?
    Mr. Harris. Yes, Mr. Chairman.
    Mr. Burton. Well compensated, or not as well as you could 
be, but you're compensated fairly well. How are the lawyers 
paid that are on the other side of the issue? Are they paid 
monthly?
    Mr. Harris. No, Mr. Chairman. They are paid at the end of 
the resolution of the cases. But the Department, frankly, 
supports interim payments for experts to help ease the costs.
    Mr. Burton. That would include the attorneys?
    Mr. Harris. I think we would be willing to discuss----
    Mr. Burton. It doesn't include the attorneys?
    Mr. Harris. No. Expert witnesses is what I'm talking about.
    Mr. Burton. But the attorney, he's the one that's putting 
all of his time into the case. If the case goes on year after 
year after year, what does he do? It ends up being pro bono. He 
just reaches a point where he says, hey, listen, I can't help 
you any more.
    Mr. Harris. I understand. We have to abide by what the 
statute requires. And the statute requires that we pay them at 
the end.
    Mr. Burton. Maybe we should pay the Justice Department 
lawyers at the end, too, what do you think?
    Mr. Harris. Not a good idea. [Laughter.]
    Mr. Burton. Not a good idea?
    Mr. Harris. No.
    Mr. Burton. You wouldn't do it, would you?
    Mr. Harris. I'm not sure it would make much difference, 
but----
    Mr. Burton. Oh, I'm sure, if you can't put food on the 
table, you wouldn't do it.
    Mr. Harris. My wife would probably strongly disagree with 
that.
    Mr. Burton. OK. I will state that the hearing record will 
remain open until November 15th, so that we can ask additional 
questions. We'd like you to submit answers to them.
    Let me just say this to you. We're going to have you guys 
back again very soon. I promise you. We're going to bring some 
more people up here and we're going to ask you to sit there and 
listen to them. And I'm going to get you a list of the cases 
that we talked about earlier, as many as I can find, so that 
maybe you can followup and maybe make their lives a little bit 
easier and make them feel like this Government is responding as 
it should to very difficult situations that they're involved 
in.
    And I have to tell you one more thing. When you're in the 
bureaucracy and you're there for a long time, and you've been 
there for a long time, Mr. Balbier, you hear, I'm not so sure 
that maybe you don't become a little callous, not 
intentionally, but I think you do become a little callous, 
because you hear so many of these horror stories. I mean, we 
don't hear that many, so many of us up here, our heart bleeds 
for these people. But you hear them every day.
    So after a while, whether you realize it or not, maybe you 
become a little callous. Not intentionally. I'm not saying 
you're a callous individual. But there is an appearance of 
defensiveness and arrogance that sometimes comes across to 
people, and they feel not only that you don't care, they feel 
hopeless. And that's really sad. So I would just say to you, 
because you're going to be there for a while, I'm sure, I can't 
do anything about that, I can drag you up here and beat you 
over the head. But I can't get you out of that job, in all 
probability.
    But I wish you would think of one thing. When you talk to 
those people, they're suffering. They're hurting inside. 
They've got a child or a sibling or somebody that's really 
suffering. So when you tell them no or you give them, do it 
with a heart. Do that for me, even though you and I may not 
like each other, you may not like me much because I'm such a 
hard nose. But if you'll do that, it would be a real favor to 
me. Because a lot of these people are suffering.
    We'll have you back here again and you can hear some more 
of their stories and we'll get some more questions answered. 
And I will submit this to you so you can take a look at that.
    With that, do we have any other questions? If not, thank 
you for being here. We stand adjourned.
    [Whereupon, at 2:04 p.m., the committee was adjourned, to 
reconvene at the call of the Chair.]
    [The prepared statements of Hon. Constance A. Morella, Hon. 
Dave Weldon, and aditional information submitted for the 
hearing record follows:]
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  THE NATIONAL VACCINE INJURY COMPENSATION PROGRAM: IS IT WORKING AS 
                           CONGRESS INTENDED?

                              ----------                              


                      WEDNESDAY, DECEMBER 12, 2001

                          House of Representatives,
                            Committee on Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 1:37 p.m., in 
room 2154, Rayburn House Office Building, Hon. Dan Burton 
(chairman of the committee) presiding.
    Present: Representatives Burton, Gilman, Morella, Horn, 
Davis of Virginia, Weldon, Duncan, Waxman, Norton, Cummings, 
Kucinich and Tierney.
    Staff present: Kevin Binger, staff director; Daniel R. 
Moll, deputy staff director; James C. Wilson, chief counsel; 
David A. Kass, deputy chief counsel; Mark Corallo, director of 
communications; Thomas Bowman, senior counsel; S. Elizabeth 
Clay and John Rowe, professional staff members; Robert A. 
Briggs, chief clerk; Robin Butler, office manager; Elizabeth 
Crane, legislative assistant; Elizabeth Frigola, deputy 
communications director; Joshua Gillespie, deputy chief clerk; 
Leneal Scott, computer systems manager; Corinne Zaccagnini, 
systems administrator; Josh Sharfstein, minority professional 
staff member; Ellen Rayner, minority chief clerk; and Jean Gosa 
and Earley Green, minority assistant clerks.
    Mr. Burton. First of all, let me apologize for our late 
start. We had a vote on the floor, and I'm sure you understand 
getting all the Members to the floor and back, it's kind of 
difficult sometimes. Mr. Waxman, I understand, will be on his 
way here pretty quickly, but in order to expedite the hearing, 
we will go ahead and start.
    Good afternoon. A quorum being present, the Committee on 
Government Reform will come to order, and I ask unanimous 
consent that all Members' and witnesses' written and opening 
statements be included in the record. And without objection, so 
ordered.
    I ask unanimous consent that all articles, exhibits, and 
extraneous or tabular material referred to be included in the 
record. And without objection, so ordered.
    Today we are holding our second hearing on the Vaccine 
Injury Compensation Program. I have made it clear that I 
believe this program has become entirely too adversarial. After 
our hearing last month, I think that most of the members of the 
committee came to the same conclusion. This is a program that's 
meant to help families that have a serious problem. These 
families have children who received serious injuries. They need 
medical care for the rest of their lives, and these are 
families that are traumatized. This program is supposed to help 
them get the compensation they deserve and they need. It's 
supposed to be fast. It's supposed to be generous. It's 
supposed to be nonconfrontational.
    What we found instead is a program that's slow and 
difficult and highly adversarial. Cases get dragged on for 
years and years and years. Government lawyers are sometimes 
very aggressive. Last month we had three witnesses testify. Two 
of them were parents of vaccine-injured children. One was the 
husband of a woman who was injured by a tetanus vaccine. They 
were each tied up in the system for over 8 years. The 
government had spent 8 years trying to prove that the vaccine 
did not cause the injury. The Government lost each of those 
cases. Those three people told us about the hardships their 
families had to endure as they went through this process. They 
told us about the tens of thousands of dollars they had to 
spend out of their own pockets while they waited for the cases 
to be resolved. They told us about how disillusioned they were 
with our government.
    Then we heard from the Justice Department and HHS. There 
was some suggestion from our government witnesses that these 
were isolated cases. I have a problem with that for two 
reasons. First, I don't think it's true, and second, I don't 
think these are isolated cases. But, that's beside the point. 
We're not talking about statistics. These are people. They have 
serious problems.
    The responses we got at our last hearing were not 
reassuring in the least. When Dr. Weldon asked Mr. Balbier if 
someone could just pick up the phone and call Ms. Zuhlke, who 
struggled through this program for 10 years after her daughter 
was injured by a vaccine, Mr. Balbier apparently had a problem 
with that. That's not reassuring. So I said, fine, we'll meet 
again in a couple of weeks. We'll bring in three more families. 
We will see if we can't convince you that these aren't isolated 
cases. They are real people who deserve to be treated with 
dignity, and that's what brings us here today.
    I intend fully to have a whole series of hearings for next 
year on a regular basis, and I ask the same people from HHS and 
Justice to come in to listen to these horror stories until we 
get some answers that are positive.
    Today we are going to be hearing from Lori Barton of 
Albuquerque, NM; we are going to hear from Tara Dyer of 
Knoxville, TN; and we are going to hear from Joseph Holder of 
Denville, NJ. And I want to thank each of one of them for being 
here today to tell us about their stories and their problems.
    At my last hearing in my opening statement, I highlighted 
the case of Janet Zuhlke because I thought it really explained 
our frustrations with the program. Janet's daughter was injured 
by a vaccine in 1990. She is now permanently disabled. She is 
mentally retarded. She suffers from periodic bouts of 
blindness. At times she is confined to a wheelchair. It took 
Janet 10 years to win compensation for her daughter because the 
government tried to prove it was caused by a strep infection. 
The government still lost. She still has not received the money 
she is entitled to because there are more hoops to jump 
through, and it's now going on 11 years, and that's just wrong.
    Today I want to again highlight one of the cases that are 
before us. All three deserve to be highlighted, but in the 
interest of time, I'm going to focus for now on the Barton case 
because I find it so troubling, and I hope my colleagues from 
government, the Justice Department and HHS, will listen to 
this.
    Lori Barton's son Dustin received his third DTP shot in 
1989. He began to have seizures. His body became rigid. He 
stopped looking at things. He became legally blind. In the 
words of Lori Barton, he was a different child. He was 
eventually diagnosed with residual seizure disease, disorder. 
In 1991, the Bartons filed a petition for compensation, 11 
years ago.
    Now, I should acknowledge from the outset that this was not 
an open and shut case. It was complicated by the fact that 
Dustin was born with a condition known as PVL that causes 
lesions on the brain. However, that does not excuse the way the 
Justice Department handled this case. They had their first 
hearing in 1993. Lori Barton and her mother testified. They 
were subjected to severe cross examination by the Justice 
Department lawyer. The lawyer tried to pick apart their 
statements like a hard-nosed litigator. Lori Barton felt like 
she was being treated like a criminal. The special master 
overseeing the case called it overkill. Despite that, the 
Bartons won round one. After it took 4 years for them to get to 
the second round, the next hearing, 4 more years.
    That was in August 1997. Three months later Dustin had a 
massive seizure, and he died. What started out as an injury 
case turned into a death case because it dragged out so long. 
In 1999, 8 years after the Bartons filed their petition, and 2 
years after Dustin died, the special master awarded them 
compensation.
    But there was one final indignity, and I want you to get 
this. The Justice Department told the Bartons that they didn't 
agree with the decision, and they didn't want it to be 
published. They were paying them, but they didn't want anybody 
to know about it. They didn't want it published. They didn't 
want it to become a precedent that might help other families, 
and if they didn't get this agreement that it wouldn't be 
published, they might appeal the decision and delay the 
compensation for another year or two. That in the private 
sector would be called blackmail, but the Justice Department 
was saying, we're not going to give you your money even though 
you have gone through this and your son died, even though it 
has taken 8 or 9 years, but we will give you the money if you 
don't publish this; but if you don't, we're going to appeal the 
case.
    Those are the kind of blackjack tactics that the American 
people just get sick about, but it happens in our government. 
And right now we've got our troops fighting overseas for our 
freedoms and this Republic that we enjoy, and we have 
government officials beating people over the head like that. 
That's not right.
    Well, the Bartons had been worn down over 8 years. They had 
lost their son. Lori's health was not good, so they agreed, and 
who can blame them. What did Lori have wrong with her? She had 
lupus. All the time she was going through this, she was 
suffering from lupus, and so she was dead tired, and she 
finally said OK.
    That's not how Congress intended for this program to work, 
and these are not isolated cases. At our last hearing I said 
that we had some clear evidence of overzealous conduct by the 
government. In the case of the Sword family, the special master 
called the Justice Department lawyer's tactics egregious. In 
the Marks case the special master called the government's 
tactics abrasive, tenacious, and obstreperous.
    In the Barton case we are seeing the same thing again. I 
have the transcript of the 1993 hearing. That's the hearing 
where the Justice Department lawyer was so brutal in her cross 
examination. I want to read to everyone what the special master 
said about the Justice Department lawyer representing the 
government. This is what the special master said, ``In my 
opinion, counsel for the respondent has unfortunately 
mischaracterized much of the testimony and much of the evidence 
in this case, which leaves the court to tend to discount some 
of her closing arguments because, frankly, they are of the 
characterization that tends to misconstrue facts in a way that 
gives lawyers a bad name.''
    They're talking about the Justice Department. They were 
giving the lawyers a bad name because of the way they were 
handling the case.
    He went on, ``Frankly, I believe counsel has been 
inaccurate and has jumped to conclusions that are not supported 
by the record and, in such a way, does somewhat of a disservice 
to the court.''
    These are our government lawyers.
    Now, that's not how Congress meant this program to work. 
Each time we see those comments from a special master, it gets 
harder and harder to believe that they're isolated incidents.
    I want to wrap up without taking too much more time, but 
there are a couple final points I want to make. The Zuhlke case 
involved encephalopathy. The Barton case involved a residual 
seizure disorder. These are conditions that everyone agrees are 
related to vaccines. They were listed in the table of injuries 
that Congress created. These are supposed to be easy cases; yet 
they took 8 years or more to decide, and they caused a lot of 
heartaches for those families.
    We have very few table cases being filed today, and this is 
due in part to the new DTaP vaccine, but it also is due in 
large part to the changes to the table of injuries. Almost half 
of the injuries that the program compensated were for injuries 
that were removed from the table of injuries by HHS. The cases 
being filed today are much more difficult. Today's cases 
involve complications related to the tetanus shot and the 
hepatitis B vaccine. They involve Thimerosal, which contains 
mercury, and autism and speech and planning delays. These are 
very difficult questions, and scientific research is woefully 
inadequate. If the system we put in place couldn't handle the 
easy cases, how on Earth is the system going to handle these 
hard new cases?
    One thing that's for sure is that we need more research on 
vaccine safety, and we can't wait. In the case of autism we 
used to have 1 in 10,000 children that were inflicted with 
autism. Now throughout the country it's 1 in 500. In some parts 
of the country it's 1 in 200 or less. We have an absolute 
epidemic, and we need to get on with finding out the reasons 
why. We can't wait, and the Federal Government needs to take 
the lead to make sure it's done.
    I also want to point out that I am very concerned about 
this business of the government pressuring families not to have 
the decisions published. I don't know if Mr. Waxman was here 
when we were talking about this, but we had a case decided 
because the government said they would go ahead and pay the 
person after the child had died, after 10 years of litigation, 
if they wouldn't publish it because they didn't want to set a 
precedent, and they literally were beating them over the head, 
and the woman who was the mother had lupus, and she agreed 
because she was simply worn down, and she is going to testify 
today.
    We're waiting for that information from the Justice 
Department that we have talked about, but the reason for it is 
very clear. The government doesn't want other families to 
benefit from those precedents when the government loses while 
the government is supposed to be helping these families, not 
putting obstacles in their path, and when we get to our second 
panel I'm going to have some very pointed questions about that.
    My final point is this. At our last hearing we heard some 
graphic testimony about injuries that were caused by vaccines. 
We're going to hear the same kind of testimony today, and it's 
important that we hear these stories, but we don't want to 
scare people into not having their kids vaccinated. Vaccines 
save lives, and vaccines injuries are rare. We would like them 
to be even more rare, and that's why I'm so serious about 
pushing for more research.
    We also want this: When a family has a child who has been 
injured by a vaccine, we want them to get the compensation they 
deserve and not have to wait 10 or 12 years until the child 
dies and to be beaten over the head by the Justice Department 
and the people who are supposed to be protecting our liberties. 
We want them to be treated with dignity and respect. We owe 
that to the Zuhlkes, and the Bartons, and the Dyers and the 
Holders. We owe it to all the other families who suffer from 
this kind of a crisis. I'm not saying that the Justice 
Department has handled every case badly, but I want what I'm 
sure the Attorney General wants, and that is for every case to 
be handled with a little compassion.
    I want to thank our witnesses for being here today, and I 
look forward to all their testimony, and I'm planning to 
introduce legislation to try to fix these problems and, 
hopefully Congressman Waxman and I can work together to get 
that problem solved. And I look forward to working with Dr. 
Weldon, who will be here shortly, who's working on this, and 
with Mr. Waxman and others.
    The hearing record will remain until December 27, and I now 
yield to Mr. Waxman.
    [The prepared statement of Hon. Dan Burton follows:]
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    Mr. Waxman. Thank you very much, Mr. Chairman, for raising 
these points. There are few strategic resources more important 
to our Nation's health than a reliable and safe supply of 
vaccines. By preventing illness, vaccines reduce the spread of 
disease and eliminate the need of costly and potentially 
dangerous treatments. It is indisputable that immunizations 
have saved tens of thousands of lives in our country and 
millions more around the world.
    Fifteen years ago the supply of vaccines in the United 
States was vulnerable. At that time pharmaceutical companies 
were threatening to leave the business of manufacturing 
childhood vaccines, citing among other things litigation costs 
as their reason for leaving. The United States was facing the 
very real possibility that we would experience a resurgence of 
such devastating illnesses as polio and measles, a disease that 
killed 450 Americans in each year of my childhood. In response 
to this potential public health crisis, Congress created the 
Vaccine Injury Compensation Program in 1987.
    The purpose of the program was threefold: first, to be a 
no-fault program to compensate people who suffer from the rare, 
but sometimes serious side effects of vaccines; second, to 
lower the number of lawsuits against vaccine companies in order 
to encourage them to stay in the vaccine business and thus to 
ensure a healthy domestic supply of vaccines; and, third, to 
allay parents' concerns about vaccine safety so that parents 
continue to have their children vaccinated.
    Now nearly 15 years later it is again time to pay attention 
to the vaccine supply. The good news is that immunization rates 
are high, and we rarely see outbreaks of vaccine-preventable 
diseases like polio or measles. While some vaccine 
manufacturers have left the vaccine business, they cannot cite 
liability as a reason for leaving. People seem generally 
satisfied with the awards they get under the Vaccine Injury 
Compensation Program. The act Congress passed allowed people to 
reject their awards and sue the vaccine manufacturers. Once 
they have gone through the program, very few petitioners have 
followed this route.
    However, there are also causes for concern. Several weeks 
ago the Federal Government reported shortages of vaccine to 
protect against the devastating disease of diptheria, tetanus, 
whooping cough and certain common forms of severe pneumonia and 
meningitis. In addition, serious delays have been noted in 
delivery of vaccines against influenza, chickenpox, measles, 
mumps, rubella, and hepatitis B. These vaccine problems are not 
due to concerns about litigation. Nonetheless, the lives of 
thousands of American children and adults are in jeopardy.
    Congress must be prepared to act in order to shore up the 
vaccine supply. I expect that the House of Representatives will 
soon pass a bill to combat bioterrorism. This legislation 
authorizes millions of dollars for the stockpiling of a vaccine 
against smallpox. Such an effort is essential, but it is 
important to keep in mind one key fact. Smallpox will only 
threaten American lives if an evil terrorist uses the virus to 
attack us. For many other infectious diseases, no terrorist 
needs to lift a finger for the health of our children to be 
threatened. Simple neglect of our vaccine supply will cause 
epidemics and claim lives around the country.
    Today we focus on the Vaccine Injury Compensation Program. 
It needs to be as fair and efficient as possible. Today we will 
hear about the problems with the program and discuss possible 
solutions, and I'm pleased that we will hear today from 
families with direct experience with this system.
    I'm also pleased we will be hearing today from the 
administration. The administration has expressed support for 
certain changes in the program, including increasing the 
statute of limitations and allowing for interim payments to 
petitioners' attorneys for their costs. These will be important 
steps in easing the burden of parents that get compensation for 
vaccine injuries, and I look forward to working with the 
administration on these changes.
    I want to comment on the point that Mr. Burton made a 
minute or two ago about the fact that after some settlements, 
people were told not to discuss their complaint. I don't know 
the facts of the case he cited, but I do know that there are 
many, many lawsuits for tort that are settled with the demand 
by the defendant that in exchange for the settlement, that all 
the facts be kept quiet. I think that's wrong. I don't think 
facts ought to be kept quiet. I don't think they ought to be 
under seal. After all, to keep facts from getting out means 
that other people won't have the benefit of the information 
that could prevent the same thing happening over and over again 
to others. Litigation may be a lawsuit between private parties, 
but there is a broader public interest, and we shouldn't allow 
the records to be sealed and information withheld when that 
information can benefit other people.
    I thank Chairman Burton for focusing attention on the need 
for a fair and efficient vaccine compensation system. I thank 
the witnesses for appearing today, and I look forward to their 
testimony.
    Mr. Gilman [presiding]. Thank you, Mr. Waxman.
    [The prepared statement of Hon. Henry A. Waxman follows:]
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    Mr. Gilman. Mrs. Morella.
    Mrs. Morella. Thank you, Mr. Chairman, and I am pleased 
that Chairman Burton is holding this hearing to continue to 
examine in more detail the effectiveness of the National 
Vaccine Injury Compensation Program. I welcome the witnesses 
today. I appreciate their coming and look forward to hearing 
their testimony. I also look forward to learning more about 
this program and its response and its service to our citizens.
    I believe that our Nation's vaccine program is first and 
foremost about the protection of our citizens and their health. 
Today many more Americans are looking at vaccines as a major 
accessory against the threat of bioterrorism. We as a Nation 
need to have in place a vaccine program that all Americans can 
trust. We need to have confidence in all aspects of all vaccine 
programs. We need to be confident in the production of vaccines 
and need to ensure that those who deserve to be compensated for 
injuries suffered from the vaccines are compensated in a fair 
and just manner.
    As a member of this committee, I want to ensure that all 
vaccine programs operate in a manner that Congress intended, so 
it is with this objective in mind that I look forward to the 
testimony of the witnesses, and, Mr. Chairman, I thank you. I 
yield back whatever time was allotted me.
    Mr. Gilman. Thank you, Mrs. Morella.
    [The prepared statement of Hon. Constance A. Morella 
follows:]
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    Mr. Gilman. Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman.
    Vaccinating children against infectious diseases has been 
one of the most effective public health initiatives ever 
undertaken in the United States. Vast nations have reduced 
vaccine-preventable diseases by more than 95 percent.
    Unfortunately vaccination programs carry a human cost. The 
U.S. Government acknowledges that a vaccine can have severe 
side effects, including death or disabling conditions requiring 
lifetime medical care. Other conditions that may be associated 
with vaccines include autism, neurological injuries, seizures, 
and a number of autoimmune disorders. These reactions can be 
devastating to an effective family.
    As a result, in 1986, the National Childhood Vaccine Injury 
Act established a Vaccine Injury Compensation Program to 
compensate individuals or families of individuals who had been 
injured by childhood vaccines whether administered in the 
private or public sector. Over the years I believe the Vaccine 
Injury Compensation Program has achieved its policy goals of 
providing compensation to those injured by rare adverse events, 
liability protection for vaccine manufacturers and 
administrators, and vaccine market stabilization. It has 
succeeded in providing a less adversarial, expensive and time-
consuming system of recovery than the traditional tort system 
that governs medical malpractice, personal injury and product 
liability cases. More than 1,500 people had been paid in excess 
of $1.18 billion since the inception of the program in 1988.
    However, there are certain aspects of the program that 
should be reviewed regularly. For example, to reserve the 
integrity of the program, it is essential to continue relying 
on scientific evidence when making additions or changes to the 
table listing the conditions that can be compensated through 
the program. Science-based changes or additions including new 
vaccines should be made promptly.
    Much of the ongoing research as well as the development and 
appropriate supply of vaccines are benefits of the program. 
Before the program was in place, many vaccine manufacturers 
stopped producing certain vaccines due to potential liability 
issues. As a result, vaccine supplies dwindled, endangering the 
health and safety of the Nation's children. The program, the 
only Federal no-fault system, has made it possible to continue 
vaccine production and research in order to improve existing 
vaccines and develop new ones. Vaccine safety research must 
continue to be a top priority, including working to eliminate 
adverse reactions.
    I want to thank the witnesses for being with us today, and 
I look forward to hearing their testimony. I yield back.
    Mr. Gilman. Thank you, Mr. Cummings.
    [The prepared statement of Hon. Elijah E. Cummings 
follows:]
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    Mr. Gilman. Mr. Duncan.
    Mr. Duncan. Thank you, Mr. Chairman, and first I want to 
thank Chairman Burton for his calling this hearing today and 
for his heartfelt concern about this issue. At our last hearing 
a few weeks ago on this same subject, I told about a woman who 
had come to see me, a constituent today, in Lenoir City, TN, 
who told me that she had taken her perfectly healthy small son 
to get a DPT shot and the severe horrible reactions that he had 
following that shot and the fact that he was now 2 years old 
and weighed 22 pounds and had continual seizures all day and 
all night long, projectile vomiting, and all sorts of horrible 
things.
    And then later I met one of my constituents, Mrs. Tara 
Dyer, who I also mentioned at the last hearing, and I'm pleased 
that Mrs. Dyer and her family are here today. She is here with 
her husband and her three children, Kaylee, Kelsee and Andy. 
Mrs. Dyer is here today to share with the committee the story 
of her son Andy, who led a perfectly normal life up until the 
time he received his first DPT shot. Shortly after receiving 
this routine vaccination, Mrs. Dyer began to notice changes in 
Andy's physical and emotional behavior, which she will discuss 
in depth today.
    Like so many of the witnesses we have before us on this, 
the Dyers are frustrated with the current National Vaccine 
Injury Compensation Program. After filing for compensation in 
1995, the Dyers had to wait until 1999 to find out they had 
been denied compensation under this program. To me as well as 
many people, Andy's case was and is one that should have been a 
clear case for compensation. Andy's vaccine came from a batch 
that was associated with 78 adverse events and 3 deaths; 44 of 
those events came solely from the State of Tennessee.
    I share the frustration felt by the Dyer family. The 
National Vaccine Injury Compensation Program has become nothing 
more than another giant government bureaucracy that is not 
operating in the spirit in which Congress envisioned.
    Mr. Chairman, I would like to thank you for conducting this 
hearing, and I think it's a very important topic, and I hope 
that we can lead to improvements because it is such a sad 
thing, as I said at the previous hearing, when parents take 
their children for something that they think is an absolutely 
wonderful thing for them to do for their health and then have 
the kinds of things happen that we heard about at our last 
hearing and we will hear about from our witnesses today.
    And I also want to welcome my constituent Mrs. Dyer to our 
hearing today. Thank you very much.
    Mr. Gilman. Thank you, Mr. Duncan. We look forward to 
hearing Ms. Dyer's testimony.
    [The prepared statement of Hon. John Duncan follows:]
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    Mr. Gilman. Mr. Tierney.
    Mr. Tierney. Thank you, Mr. Chairman. I want to thank you 
and I want to thank Chairman Burton for having this hearing 
today. I understand the Federal Government sets up systems, our 
judicial system, obviously, to the Constitution and this system 
with the best intentions. The intentions are to solve and 
resolve issues and problems that our population has. We don't 
always get it right, and I share the frustration of many people 
here that this particular system that was set up had all of the 
best intentions and has resolved for a lot of people some of 
the issues, but as for some, obviously, appears to be missing 
the mark.
    The testimony we heard in our previous hearing on this 
subject was moving and was also troubling. In each of the cases 
the witnesses described how they waited for years for 
compensation while the Justice Department seemed to be 
obstructing their efforts, and for this reason I'm glad that 
we're going to have the opportunity to hear again some more of 
the possible changes that are needed.
    The program, the compensation program, was created to 
provide assistance to individuals. Last month we learned that 
this is not quite the less than adversarial system that we 
hoped it would be, and it is looking more like the traditional 
tort system that is cumbersome, it is long in process, it is 
very adversarial.
    When the committee first reported out this particular piece 
of legislation, it indicated that it chose to provide 
compensation to all persons whose injuries meet the 
requirements of the petition in the table and whose injuries 
cannot be demonstrated to be caused by other factors. But the 
testimony that we've heard recently and the testimony we are 
going to receive again today seem to indicate quite clearly 
that the Department of Justice does not always seem to have 
followed the committee's intent. We heard from families of 
several individuals who described years of what they believed 
was stonewalling. It was followed by subsequent appeals by the 
Department of Justice. For those families it took an 
unacceptably long amount of time to be compensated.
    I think the testimony of our witnesses today may surely be 
further evidence that the individuals we heard from last month 
were not merely telling us about anecdotal evidence, but 
something that is real. The Department continues to claim that 
these cases are not representative about the manner in which 
they treat most vaccine injury compensation cases, but the data 
that was provided by the Department shows that the majority of 
cases that have been appealed for which the initial decision 
favored the petitioner also had the appeal resulting in favor 
of the petitioner. That strongly supports that the claims we 
heard last month indicating that the Department of Justice is 
being overly and perhaps wrongly adversarial.
    There are a number of other improvements that are needed in 
this compensation program, and I think I look forward to 
examining all of them. I'm pleased that there seems to be some 
areas of consensus among members of the committee on both 
sides, including support for the payment of interim fees to 
attorneys working on behalf of claimants. I think we should be 
able to find a way to make that change quickly to begin to 
properly defray the families' obligation to their counsel while 
they are pursuing these matters.
    While I may not, Mr. Chairman, be able to stay for all of 
the testimony, it will be taken down and will be available for 
us to read.
    I think, as I said earlier, it is important for this 
committee to hear the circumstances. I regret that these 
families have had to live under these circumstances and just 
pledge that this committee will work together to try to resolve 
this so that others will at least benefit from your experience. 
Thank you.
    Mr. Gilman. Thank you, Mr. Tierney.
    Mr. Horn. Thank you, Mr. Horn.
    I would like to welcome the panelists and thank Chairman 
Burton for holding this hearing today. We look forward to 
hearing from the witnesses as our committee continues to 
examine the effectiveness of the National Vaccine Injury 
Compensation Program. In 1986, when Congress passed legislation 
introduced by the ranking minority member, Mr. Waxman, it 
intended to provide fair compensation to individuals harmed by 
vaccines while ensuring that the vaccine manufacturers would 
continue to supply and create safe vaccines for the American 
public. Instead the program has become bogged down in 
litigation in cases lasting years, facing numerous levels of 
appeals before any final decisions are made.
    During my years in the Congress, I have been contacted by 
many families, all of whom experience varying levels of 
difficulty with their claims before the compensation program 
ranging from being forced into long, drawn-out court battles to 
outright denial of claims due to changes in definitions and 
criteria.
    One such example is Tommy Sansone, Jr. Tommy's family has 
been trying to receive compensation for the lingering 
devastating effects of a DPT vaccine he received when he was 
just 6 months old. His family tried to file a claim immediately 
after their son developed a severe chronic seizure disorder 
less than 2 weeks after receiving the vaccine. Regrettably they 
were told that before a claim could be filed, the family needed 
to spend more than $1,000 in nonreimbursable vaccine-related 
expenses before they can file such a claim, and since Tommy was 
covered by his father's insurance plan, it took several months 
before the Sansones met that monetary requirement. By that 
time, however, the criteria for the DPT vaccine had been 
changed, eliminating seizures from the table of related side 
effects. For 10 years a large percentage of those with brain 
damage and other symptoms were recognized to be DPT injuries, 
but by 1995, the year in which Tommy's claim was made, it was 
no longer recognized. Those new definitions have had unintended 
consequences, using criteria that is so strict that the 
restitution fund pays fewer claims than before despite the fact 
that there's over $1.7 billion in that fund today. As a result, 
the families of children like Tommy find it virtually 
impossible to win a claim against a vaccine injury compensation 
program. That was over 6 years ago and thousands of dollars in 
medical expenses later.
    Congress envisioned that the program would be a simple one, 
would be straightforward and more streamlined than typical 
litigation. Somehow congressional intent was lost along the 
way. Tommy faces a lifetime of crippling seizures and mounting 
medical bills in addition to the emotional strain on him and 
his family. Hopefully these hearings will lead to a necessary 
adjustment to the program and will finally help children like 
Tommy receive the kind of compensation to which they are 
entitled.
    Mr. Gilman. If there's no further opening statements, we 
will now hear testimony from the first witness panel, which 
includes--and I'd like to ask the witnesses to take their 
seats--Lori Barton, Tara Dyer, Joseph Holder, Clifford 
Shoemaker, and Robert Block, Dr. Block. Please approach the 
witness table, and I'm going to ask you to please, before you 
are seated, raise your right hands.
    [Witnesses sworn.]
    Mr. Gilman. The witnesses have indicated yes. Let the 
record reflect that the witnesses have responded in the 
affirmative.
    Please be seated. On behalf of the committee we welcome you 
today. We will start with Ms. Barton. You may summarize your 
testimony, and we will put the full testimony in the record, or 
you may read, whichever you deem appropriate. Please proceed, 
Ms. Barton.

    STATEMENTS OF LORI BARTON, ALBUQUERQUE, NM; TARA DYER, 
  KNOXVILLE, TN; JOE HOLDER, BAYONNE, NJ; CLIFFORD SHOEMAKER, 
LLP, ARLINGTON, VA; AND ROBERT BLOCK, M.D., CHAIRMAN, ADVISORY 
        COMMISSION ON CHILDHOOD VACCINATIONS, TULSA, OK

    Ms. Barton. My name is Lori Barton, and I'm here speaking 
on behalf of my son Dustin. Dusty was born on July 14, 1988, 
slightly premature, apparently normal, with Apgar scores of 8 
and 8. He and I went home after 3 days. He developed normally, 
lifting his head, recognizing favorite items, learning to rock, 
roll from stomach to back and finally at 5 months starting to 
rock on his hands and knees as babies do before they begin to 
crawl.
    He had his DPT shots as scheduled at 2, 4 and 6 months, 
September 15, 1988; November 16, 1988; and January 18, 1989. 
After his first DPT vaccination, he cried for 24 hours straight 
until he would exhaust himself to sleep for a few minutes at a 
time. Before the second DPT I asked the doctor, Dr. Marek, who 
was our family doctor, about this reaction to his first 
vaccine. He said it was a normal reaction and, ``He's fine 
now.'' Besides, is it was, ``the law that required the 
vaccines,'' which I found out later was not exactly true.
    So we gave him the second DPT. This time was much worse. 
His continuous screaming lasted for at least 2 days, with weeks 
of intermittent bouts of screaming. He had begun to roll over 
from stomach to back and could no longer do this. The doctor 
said the screaming was colic, and that it was probably a fluke 
that he had rolled over and would do it again real soon.
    My mother baby-sat Dustin while I worked and was going to 
take Dusty for his third DPT shot. She and I talked about both 
our reservations regarding this shot, and she was going to ask 
if it was absolutely necessary he receive it. I told her she 
could ask, but I trusted this doctor and said if he said he 
needed the shot, then we would have to go ahead and give it to 
him. This was January 18, 1989.
    That night Dustin began to exhibit what I then called 
shivers. I called my mom, and she told me to phone the doctor. 
Dustin was just stiff. The doctor told me that Dusty probably 
had a low-grade fever and had developed a habit out of these 
shivers. This time, though, there was no crying, and Dustin was 
unusually quiet. From 24 hours after the third DPT shot until 
11 months of age when he began physical therapy, he was 
virtually without movement except during his shivers, which I 
later found out were seizures.
    We finally started taking Dustin to other doctors. We took 
him to a pediatric ophthalmologist because he was no longer 
looking directly at us, who told us Dusty was legally blind. He 
went from seeing and laughing at fans on the ceiling to barely 
seeing brightly colored objects right in front of him.
    Our initial doctor, Dr. Marek, testified against us at the 
first evidentiary hearing. The special master found him to 
have, ``selective memory.'' She also asked him if he wrote 
everything in his medical records. He said only if he deemed 
them medically necessary. The special master then asked him if 
he would write down the words of a hysterical mother or 
grandmother, which is what he had called us. His answer was no.
    I accidentally found out about the compensation system and 
the VAERS. I was in a support group for parents of disabled 
children, and one of them showed me some information on a group 
called DPT, Dissatisfied Parents Together, which I joined. They 
sent me a law firm directory, and from there I picked a lawyer 
and wrote him a letter.
    This case was filed on November 15, 1991. Elizabeth Kroop, 
the Department of Justice attorney, was assigned this case for 
the respondent. The first evidentiary hearing was held 2 years 
later on September 28 and 29, 1993. At that time the Justice 
Department attorney treated me and my witnesses, my mother and 
two friends, as if she were prosecuting a criminal trial and we 
were the criminals. She was rude and actually cruel to my 
mother, insinuating that she was not a good caretaker of 
Dustin. At one point she almost had my mother in tears, and in 
walked our old doctor, Dr. Marek, who had to testify right 
then. So my mother had an overnight reprieve. All I could tell 
her was to not let the Justice Department attorney get to her. 
We didn't do anything wrong. The next day my mom did much 
better. At the end of the hearing, the special master berated 
Ms. Kroop for her treatment of us, as you heard in Chairman 
Burton's opening statement.
    It was found at that hearing that Dustin did have a table 
time injury from his third DPT shot, and he had a resulting 
seizure disorder from this injury.
    After agonizing delays, I even commented to family and 
friends that the government was waiting for Dustin to die so 
they would only have to pay a death benefit.
    The second hearing finally occurred on August 7, 1997. This 
was the hearing of the expert witnesses. Again during this 
hearing the Justice Department attorney was very abusive toward 
me and even called me a liar because she asked when Dustin 
became a patient of his current neurologist. I gave her the 
date that we actually became--began a doctor/patient 
relationship with him. She brought out this paper and showed 
the date was earlier than I had said. I had taken Dustin to 
this neurologist about a year before for a second opinion and 
had forgotten about that. Through the rest of the hearing she 
would comment on my credibility because of that one incident.
    Closing arguments were to be scheduled for a later date, 
but on Friday, October 24, at about 9 p.m., my husband and I 
put Dustin to bed. Before going to bed myself, I checked on all 
three of our boys. Dusty was sound asleep on top of his 
blankets, which is where I had put him earlier. I covered him 
with his blankets and left the room. He was sleeping soundly, 
snoring a little, as usual, and breathing fine. It was about 
12:15 a.m., October 25, 1997.
    Early on October 25, Dillon, my 5-year-old, woke me to fix 
breakfast. I got up, dressed, and fixed cereal for Dillon and 
Shane, my 10-year-old. I began to fix Dusty's breakfast because 
he normally was awake by this time, and even if he wasn't, he 
would awaken while we were fixing his breakfast. When I didn't 
hear him, I went to his room. The time was approximately 6:25 
a.m. The first thing I noticed was that his blankets were all 
wrapped around his legs. This was very unusual as he didn't 
normally move much in his sleep, especially his legs. He did 
not have much muscle control or strength in his legs. He was 
facing away from the door, so I went around to the other side 
of the room and squatted down beside him to wake him. When I 
touched Dustin's face, it was cold.
    I ran into my bedroom to grab the cordless phone, screaming 
for Kevin to get up. I dialed the speed dial number for my 
mother and said, come over, I have to call 911. I hung up and 
dialed 911 as Kevin began to give Dustin CPR. I gave directions 
to the emergency service and then took over the CPR. Within 5 
minutes the paramedics arrived. My mother and father were there 
2 minutes later. We were at the hospital by 6:50 a.m., and 
Dustin was pronounced dead 10 minutes later. The staff at the 
hospital believed he had died about 3 hours earlier. The ER 
doctor said that she believed Dustin to have died of a seizure 
and that an autopsy wasn't necessary, although Dustin's 
pediatrician felt that we should have one done as she had not 
seen Dustin since January or February of that year because he 
had been so healthy.
    Before he died, Dustin was making great progress. He could 
walk short distances with his walker, crawl wherever he wanted 
to go, and speak well enough for family and friends to 
understand.
    After receiving the death certificate showing the cause of 
death as seizures, I filed a motion to recaption and convert 
the case to a death claim.
    About this time I also heard from Dustin's neurologist and 
the pathologist who did the autopsy saying that the Justice 
Department attorney did her best to intimidate them as well. 
This was January 1998. At this time a new Justice Department 
attorney, Mike Milmoe, was assigned Dustin's case. Dustin's 
attorney, Bob Moxley, informed Mr. Milmoe that I had been 
diagnosed with cerebritis as a result of my lupus, and the 
doctors told me I had little time left to live. After Mr. 
Milmoe was granted many more delays, the final arguments were 
heard. Special Master French filed her published decision on 
May 2, 2000. The respondent filed a motion to reconsider, which 
was granted. The final decision was filed June 1, 2000. This 
final decision was again in our, the petitioners', favor, only 
it came with a condition. The respondent promised not to file 
another appeal in this case if we agreed the decision be 
unpublished.
    I agonized over this decision as that meant no other family 
would be able to cite this case in any of their proceedings, 
but in the end my fatigue won out. I was mentally and 
physically exhausted and was also quite ill. I didn't think I 
could make it through another 10 years of appeals and motions. 
Luckily my lupus has gone into remission and is no longer a 
major threat to my life.
    I also didn't want Dustin's lawyer, Bob Moxley, to go 
through another 10 years of working on our case without getting 
paid, and I had already borrowed thousands of dollars in expert 
witness and attorney expenses from Dustin's grandparents. I 
felt after 10 years of work, his attorney deserved to be paid 
as well as all four of Dustin's grandparents.
    I believe the attorneys should be paid in increments after 
it is proven that the case is not fraudulent. I also believe 
that families whose cases drag on for years should receive 
moneys for those years their cases were in the system. Even if 
the child should die during the process, the family has been 
fighting with the government to get help for their child while 
doing it all along.
    I also believe there should be a limited number of 
extensions and delays granted to each party. I believe that 
doctors should be well educated on what to look for in vaccine 
adverse reactions. I'm sure Mr. Milmoe's tactic of published 
versus unpublished must be legal, but to me it was extortion.
    I initially filed this claim so if any money were ever to 
come of it, it would help Dusty when he needed it, but that 
never happened. It took almost 10 years to settle this, and 
Dustin died in the process. It seems to me the government got 
what it was waiting for, a death benefit.
    I often wonder if the case had not dragged on for so many 
years, if Dustin's outcome would have been different. He would 
have had the money to seek treatment and therapies outside of 
Albuquerque that his insurance would not cover. Maybe one of 
those could have saved his life.
    Mr. Burton [presiding]. Thank you, Ms. Barton.
    [The prepared statement of Ms. Barton follows:]
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    Mr. Burton. I had read your story before, so I apologize 
for not being here at the beginning of your testimony, but I 
want you to know we are very sympathetic to the problem you 
had, and yours is another story that we shouldn't have to hear. 
We just shouldn't have to hear.
    Ms. Dyer.
    Ms. Dyer. Good afternoon. My name is Tara Dyer. I'm the 
mother of three, Kaylee, who is 14; Kelsee, who is 12; and 
Andy, who is 9. I'm here on behalf of my son Andy, who at 2 
months of age suffered brain damage as the result of a required 
vaccination.
    Andy was a perfectly healthy baby at birth with Apgars at 9 
and 10 respectfully. The first 2 months of his life were 
uneventful. He would respond happily to his surroundings, 
laughing and giggling when spoken to, tracking with his eyes, 
kicking with his arms and legs when recognizing familiar faces, 
and he had a very hearty appetite.
    On August 28, 1992, I took Andy in for his first DPT 
vaccine. As I did with his sisters previously, I gave him 
Tylenol beforehand to help with any fever that might incur. 
After his first shot, he began to show symptoms that were 
unknown to me to be associated with vaccines. The first thing 
that I remember that was different with Andy's shot was that he 
cried much louder and longer than did his sisters. By the time 
the nurse came to tell us we could leave, he had virtually 
cried himself to sleep. He slept all the way home and 
approximately 3 hours thereafter. He completely missed a 
feeding, and I was sure that when he awoke, he would be 
starved. However, upon awakening, he seemed to have difficulty 
sucking, and my assumption was that he was still sleepy. We 
were told that being sleepy after the vaccination is normal.
    Andy continued to run a mild temperature, sleep more than 
usual, and not eat as he normally did.
    After about 48 hours, his fever broke. Yet he seemed more 
quiet and much more lethargic than before.
    On September 2nd, I took Andy to his pediatrician for a 
scheduled well baby visit. The doctor felt Andy was all right.
    During September 3rd through the 14th, Andy developed 
symptoms which to me appeared to be cold related. He appeared 
to be having difficulty breathing, as if he had a stuffy nose. 
He was not eating well, and this I associated with having the 
difficulty breathing.
    Then we noticed Andy flicking his ear occasionally. At 
first we thought that he was just playing with his ear. Then we 
noticed that he was doing this cuffing and flicking several 
times a day.
    At this time I believed that Andy had possibly developed an 
ear infection. I took Andy to the doctor again and told him the 
things Andy was doing. The doctor diagnosed him with an upper 
respiratory infection. He was put on antibiotics and Dimetapp.
    Within days the flicking of the ear episodes turned into a 
complete stiffening of the body along with the flicking of the 
ear. We videotaped this and took it to the doctor. He was then 
diagnosed with a seizure disorder. It is now known that the 
difficulty breathing, not wanting to suck and the cupping and 
flicking of his ear were all effects of neurological damage 
taking place, not an upper respiratory infection.
    During the next 2 years, we were seen by several 
specialists to try and find out why Andy was having these 
uncontrollable seizures. There was no history of seizures in 
our family. During this time, his seizures continued, as did 
his delayed development. Never during these 2 years was there a 
mention that there could be a relationship between his shot and 
the brain injury.
    Shortly after Andy's second birthday, a friend mentioned 
that she had seen a show on vaccines and children with seizures 
and other disorders. This is when I began to research Andy's 
vaccine.
    The first vaccine Andy received was Lederle 322914. I found 
that there was a suspicious clustering of events with this 
vaccine. This lot contained 78 events with 3 deaths; 44 of the 
78 were from Tennessee, as were the deaths. All of these 
occurred between February 1992 and June 1993. It is known that 
vaccine lots manufactured by Lederle, which have the same first 
three digits, are all from the same bulk of vaccine. Therefore, 
his lot contained a reported--again, I just say reported--total 
of 246 events and a total of 12 deaths. This is substantial 
evidence that my son received a bad batch of vaccine.
    Why after so many deaths and events was this still being 
given to our children? Because the FDA says there is no trigger 
number for a recall. The lot distribution number, including the 
number of doses per lot, is confidential. Can you believe this? 
The lot distribution number is confidential? To this day, we 
still do not know how many doses and how many adverse events 
occurred.
    At the age of 3\1/2\, Andy was diagnosed as having a 
seizure disorder and being severely developmentally delayed. He 
could walk, but communication was very limited. At this time, 
he developed liver failure due to the anticonvulsant he was 
taking. He was in a coma for 8 weeks, and when he came out, he 
had lost all neurological function, except for the ability to 
breathe on his own.
    We were told that he would never walk, talk, or eat orally 
again. We were told that he was blind and that he was deaf as 
well, all of this stemming from a required DPT vaccination.
    My experience with the Vaccine Compensation Injury Program 
was not a pleasant one. First of all, I believe this program 
was intended to be generous, user-friendly, fair and expedient. 
It fails in all of these areas.
    We filed for compensation in July 1995. We were denied 
compensation in August 1999. Going into the hearing after being 
assigned Special Magistrate Millman, we felt prejudiced against 
before ever even starting. She is quoted as saying in the 
Washington Post, ``when I have to refuse an award, it is hard, 
but I know these children's basic needs are going to be taken 
care of either way. It is not like the ancient days when they 
just threw you off a cliff.''
    How dare this government official imply that it won't 
bother her not to grant an award for a vaccine injury, we 
should be happy our child is just not being disposed of? And, 
as far as basic needs, these children need much more than food, 
clothing and shelter. There is the therapies, medications, 
special equipment. There is wheelchair lifts, ramps, adapted 
bathrooms and beds. The list goes on.
    As my husband and I get older, we worry as to what will 
happen when physically or mentally we can no longer care for 
Andy. As with our healthy children, we want these injured 
children to live under the best circumstances possible and be 
the best and most that they can be.
    We hear daily of awards being given to cancer victims or 
their families because of cigarette smoking. These are people 
who made the decision to smoke, even though they were misled as 
to the dangers of tobacco, but these same people are 
justifiably compensated for their injuries. Why can't our 
children be compensated for injurious, mandatory vaccinations? 
Why are they receiving nothing?
    One reason is because the timetable is next to impossible 
to meet unless yours is a child who dies. Many symptoms are 
delayed and appear not to be life threatening.
    Is your child extremely sleepy, or are they actually 
suffering, ``a significant change in mental status?''
    Is your child playing with his ear, or is this, 
``repetitive movement of the part of his body a seizure?''
    Is my new child just not hungry, or is there difficulty 
sucking, quote, an injury to the neurological function?
    These were signs my son showed, yet I did not know how to 
recognize a severe vaccine reaction so that I could report it 
to the doctor, and I believe many parents have received to the 
same. Had the facts been given to parents whose children 
received the contaminated vaccine, parents could have been 
spared much wasted effort, and the child could have been 
committed to earlier and more meaningful treatment.
    We were told that, in order to receive compensation, 
injuries should have been indicated within 72 hours. How could 
this have possibly been done if we didn't even know it was the 
vaccine until nearly 2 years later?
    Second, it has been stated numerous times the burden of 
proof is on the petitioner. We are continually put in the 
position to prove that there was not some other cause.
    One, my child was normal at birth and until his first 
vaccine was developing normally. Two, he immediately showed 
signs of a reaction after the vaccine. Three, the vaccine 
itself showed to be a hot lot. Four, after many tests and no 
other explanation, Andy's neurologist believed the vaccine to 
be the cause.
    We know of no other children unaffected who partook of this 
bad batch of vaccine. As far as we are concerned, 100 percent 
of those who were immunized by this bad batch were affected. 
This is more than substantial proof. If you have a glass of 
water and 100 kids take a drink and 100 get sick, there is 
something wrong with that glass of water.
    The standards need to be changed and made retroactive. Much 
of the testimony given in these cases is more than required in 
a normal court of law. I have read that the NVCP was, ``not 
intended to serve as a compensation source for a wide range of 
naturally occurring illnesses and conditions.'' If this is the 
case and a petitioner has given substantial evidence that this 
was not a naturally occurring illness, the burden of proof 
should now be on the government to prove that it was not the 
vaccine.
    If this drug were an automobile, a car seat, a toaster, a 
toy, how much more aggressive action and remedy would be taken 
against the manufacturer in favor of the damaged individual?
    Finally, finding a qualified attorney who is willing not to 
receive compensation until the claim is settled is very hard. 
These attorneys are required to cover all costs incurred for 
medical experts, copying charges, mailing charges, telephone 
communications, etc., severely taxing theirs and the 
petitioner's resources, while the government attorneys receive 
regular pay, pay increases and other benefits and are able 
financially to access an unlimited amount of resources. This 
makes for a very uneven legal playing field.
    Additionally, that can drag out the process, discouraging 
and stretching the petitioner's resources to impossible limits.
    Do any of you know what it is to watch day in and day out a 
child who lives and moves essentially in only two dimensions on 
the floor, have a 9-year-old who has never experienced running 
through the grass, hitting a ball, stubbing his toe, telling 
his parents and family members that he loves them or requesting 
a gift from Santa? Realize that your child will always have to 
wear diapers, realize that your child will never participate in 
a team event, date, attend a prom or bring home a report card, 
or see a lonely child in a corporate-produced solitary 
confinement, while that corporation thrives on the pain and 
deaths of children?
    Is it too much to ask that once a drug such as this is 
found to be deadly, its use is immediately stopped, 
participants notified, causes determined and corrected and 
injured children compensated?
    In closing, thousands and thousands of children are injured 
or die each year due to vaccines. However, I wonder how many 
more like me are out there who do not know and maybe still do 
not know that their child's death or injury was vaccine-
related? And how many doctors are not reporting these events? I 
believe the true number of injured children is much higher, and 
these injuries do not just affect the child but the whole 
family. There is depression, resentment from other children for 
time taken away from them and tension between the husband and 
wife.
    But there is also good that comes from such a tragic 
event--an appreciation for the small things, a hug or a touch, 
the voice of someone saying I love you. It is often in the very 
midst of adversities that we experience God's love, the 
kindness of a neighbor, the prayers of a church family and a 
peace that could only come through faith in our Lord Jesus 
Christ. My prayer is that Andy's story can make a difference, 
and I thank you for the opportunity to share it. God bless you 
all.
    [The prepared statement of Mrs. Dyer follows:]
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    Mr. Burton. I would like to have the information on that 
lot number that you can't get. I will subpoena that today. We 
will subpoena that, and if the company does not give us that 
information, I will have--was it Lederle?
    Mrs. Dyer. Lederle.
    Mr. Burton. We will subpoena the president of the company 
before the committee to ask us why they would not give us that 
information. And you said, to your knowledge, every child that 
got a shot from that lot was adversely affected?
    Mrs. Dyer. It has not been proven to me otherwise.
    Mr. Burton. I see. OK. I want you to know that, in defense 
of some of the doctors and maybe because of their own 
carelessness, many of them don't know what is in these shots. 
Every Congressman that is concerned about the flu vaccine, 
about getting the flu because of anthrax, we're all going over 
to the doctor's office here at the Capitol, and we're all 
getting flu shots, and what no Congressman knows or very few 
knows is that the shots we're getting contains mercury, 
mercury, a toxic substance that they won't even allow in 
topical dressings, and scientists all around the world 
including Canada have told us that mercury, even as a topical 
dressing, has adverse effects. But as a shot--given in a shot 
as a preservative, that it can cause--it is a contributing 
factor to autism and Alzheimer's.
    A lot of us are older guys here in the Congress, and we're 
getting shots we don't even know contains mercury because it is 
called thimerosal, and I don't know why the FDA doesn't do 
something about that. We've talked to them until we're blue in 
the face, and we'll ask them about that again at later 
hearings. You'll hear about that, guys, again. You'll be back 
up here again.
    But it really is kind of troubling that we're not getting 
answers to these questions.
    Be sure to give me that lot number, and we will subpoena 
that today.
    Mr. Holder.
    Mr. Holder. Thanks very much for having me here. It was 
kind of short notice. I'm real glad I could make it.
    I'm here on behalf of my son, Brandon Holder; and please 
let the record show I'm from Bayonne, NJ.
    Anyway, Brandon was born on January 7, 1992. His Apgar was 
a 9 and 10. He was injured when he was 5\1/2\ months old on 
July 10, 1992, from his second DPT vaccination; and his first 
seizure occurred 6 hours later, which was a generalized 
seizure.
    We found out about NVIC by chance in April 1993 when 
Brandon was hospitalized for multiple seizures. A woman whose 
child was in the same room informed us of the NVIC at this 
time.
    There was a lot of difficulty finding an attorney who would 
handle the case, but we finally located Tom Gallagher in August 
1994. The claim was filed in October 1994 and resolved in July 
2000, a total of 6 years from beginning to end.
    Throughout this period, Brandon's development regressed 
daily. Medical bills piled up. His mother quit her job to care 
for him. Bankruptcy was filed, and I worked three jobs to make 
ends meet.
    We helplessly watched as the seizures gradually changed 
Brandon from a brilliant child who could say his ABCs, count to 
20, pledge allegiance to the flag and meet most of his 
milestones to a child who has a limited vocabulary and the 
mentality of a 2-year-old.
    Upon the settling of the case, a lump sum was put into an 
irrevocable trust for Brandon by the laws that govern the State 
of New Jersey. Several things were outlined in Brandon's life 
care plan as to how this money should be spent. One example of 
this was financial assistance toward a home in light of our 
past monetary problems due to Brandon's condition, the logic 
being that with all of our lost time and wages that it was fair 
to assume that, being productive individuals, we would have 
achieved home ownership by this time. A specific amount was 
outlined, and to date the bank holding the trust has denied our 
request for assistance based on the laws that govern New 
Jersey.
    Basically, New Jersey law states that you must go to court 
to prove you need the assistance, while the Federal Government 
has already acknowledged and made provisions for the assistance 
that is required within the life care plan. Keep in mind this 
is just one example of how difficult it is to access the money.
    The flaws in this program are to me very plain.
    First and most important for the child is the amount of 
time that case takes to settle results in lack of quality, 
early intervention for the injured child and financial 
difficulty for most parents. I believe that had the case been 
settled in a more timely fashion, Brandon would have been able 
to get sufficient early intervention from quality 
professionals, and he may not have regressed as drastically.
    The second one is the inability of the Federal Government 
to fulfill the terms of its settlement because of the laws that 
dictate State government. You should not have to prove your 
need for something to the State that has already been approved 
on a Federal level.
    And if one of the primary purposes of this program is to 
provide fair and expedited compensation, I can agree that the 
settlement was fair but far from expeditious. Claimants are 
left to suffer for years before receiving compensation and then 
years after trying to justify to their State government that 
which was already promised by the Federal Government.
    And that is pretty much all I've got. Thank you.
    Mr. Duncan [presiding]. All right. Thank you. Thank you 
very much, Mr. Holder.
    [The prepared statement of Mr. Holder follows:]
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    Mr. Duncan. Mr. Shoemaker.
    Mr. Shoemaker. Thank you, Mr. Chairman.
    First of all, I'd like to say that I'm honored to be on the 
panel today with Dr. Block, who, as many of you know, is 
retiring as chairman of the Advisory Commission on Childhood 
Vaccinations; and I think we all should thank him for his role 
in that capacity and the work that he has done over the years. 
And I'm honored to be with you today on that.
    I'm even more honored to be on the panel with the parents 
of Brandon and Andy and Dustin. These are stories that, 
unfortunately, I hear every day of my life. I brought along 
some of the members of my office, and I'd like them to stand 
up, if you don't mind, please. These are some of the people 
that hear these stories every day of their lives, too, and I 
think they were entitled to be here today.
    Today, we represent over 400 children and adults in the 
Vaccine Compensation Act, and I think Dr. Block and I will 
agree on a lot of things here today. One is that adverse 
reactions to vaccinations are rare. Vaccinations have done more 
for public health in this country than--I can't say how many 
things. Clean water, vaccinations--there are a few things that 
we can point to--antibiotics--that have done a lot for this 
country. So both of us agree that these vaccine adverse 
reactions are rare, but when they happen to your child, that is 
100 percent. That is very real.
    There was something in Dr. Block's testimony that I would 
like to read--and he's going to be reading it to you. He says, 
speaking for myself, I think it is sad that a child allegedly 
injured by a vaccine can turn to the program for compensation, 
but a child injured by a vaccine-preventable disease may have 
little or no access to appropriate care and no source for 
financial resources to support that care.
    I know what he's talking about there, because the year I 
was born, my sister had polio. There was no program to pay for 
her expenses. There was no vaccine to protect her. So polio 
vaccination has been a very important thing in this country, 
and I recognize that. But I think my sister would be the first 
person to say that Zachary Strain who lives up in Syracuse, NY, 
deserves the benefits of this program.
    At 2 months of age, Zachary was given oral polio 
vaccination. Today he is paralyzed from the neck down, on a 
respirator for life because he has polio from that vaccine. Now 
this was after the recommendations had already been changed 
saying that they should give the kill virus vaccine first. I 
don't know why he was given an oral polio vaccine at 2 months, 
but he was, and today he's paralyzed from the neck down.
    And that little boy is a beautiful child. He is so smart. 
He's been living with nurses all of his life. He has a 
personality that is years older than him. He flirts with the 
nurses. But for the rest of his life, he will be paralyzed and 
on a respirator. And my sister, who had no compensation program 
when she developed polio, would be the first to say that 
Zachary Strain needs to be taken care of.
    A little bit of an update on Rachel Zuhlke, who is our 
client. Rachel is back in the hospital, I'm sorry to say. She 
is still having continuing problems.
    We are working now actively on the life care plan, because, 
as you pointed out, we did win the compensation in that case, 
the entitlement portion of that case.
    There were a lot of reasons why Rachel's case was delayed 
over the years. Some of them were my fault. Some of them were 
not my fault. Every time we'd get ready to go to a hearing, 
Rachel would end up back in the hospital. Then we would have to 
go get more records and provide more records to the experts.
    But the important thing to understand about Rachel's case 
is the treating doctors all said this was postvaccinal 
encephalopathy. Dr. Rick O'Hearn in Dr. Weldon's district, a 
great pediatrician, a wonderful man, said this is a 
postvaccinal encephalopathy. John Sleasman, the head of 
immunology at Shands, who I think Tim Westmorland knows, said 
this is postvaccinal encephalopathy.
    This wasn't a case that should have ever been challenged, 
but it was. Experts were hired. So we had to hire experts and 
bring them in, and the expenses of these cases are 
unbelievable.
    There came a point in time when the government wanted to 
have all of the radiological films in that case. It would have 
cost $5,000 or $6,000 to produce those films. I said I don't 
have the money.
    At first, the government was going to pay for it. Then they 
said, no. No, we can't do that because if we do it in this case 
it will set a precedent. We'll have to do it in all the other 
cases.
    So I said to my client, I don't have $5,000. I'm 
representing hundreds of people. I don't have--you know, you 
can't squeeze blood out of a turnip. I don't have it. So she 
went and put $5,000 on her credit card to pay for those films 
to be sent.
    I don't know how much money Mrs. Zuhlke spent over the 
years helping us to finance that case because I couldn't pay 
the expenses. For me as an attorney, that is embarrassing.
    But do the math. We represent 400 children in the program. 
At $150 apiece for filing those cases, that is $60,000. If it 
only costs me $500 apiece to get the medical records, that is 
$200,000. If I only pay one expert $1,000 to get a report in 
each of those cases, that is $400,000. I have a half a million 
dollars outstanding in expenses in these cases. I have no more 
to give.
    I don't care if this program is adversarial. Make it 
adversarial, but give us the resources to fight the battle. 
Give us the money to be able to pay for the experts, to do 
things that I know need to be done to win these case. I can win 
them, but I can't win them without resources.
    I'm getting $190 an hour in this program. My colleagues who 
are out there in contingent fee litigation think I'm an idiot. 
They think I'm crazy.
    But the reason I'm still in this program is because of 
people like this. These are saints. They live day in and day 
out with devastated children. I could bring you videotapes that 
would make you bawl, because we see them every day. I saw one 
this morning, a child violent, throwing things around the room, 
his parents trying to control him. I can't take that very much 
longer. I don't care if it is adversarial. Give us the 
resources.
    There are three things that I asked for in September 1999. 
None of them have been done.
    The next paper I write is not going to be for Congress. It 
is going to be for the American Trial Lawyers Association 
magazine, saying tort reform is dead. It does not work. Any 
child can go out there on the street and be injured in an 
automobile accident, and they don't have to file a lawsuit 
until they're 18 years of age or older. And yet every day I get 
phone calls from people saying, 4 years ago, 5 years ago my 
child was injured. And I have to sit there and explain to them, 
I'm sorry, the Federal Government won't let you make a claim 
because it is more than 3 years from the onset of your 
symptoms.
    I know that some of you on this panel are lawyers. Read 51 
Am. Jur. 2d Limitations of Actions, section 178 and 747. They 
are on the front page. Every State in this Union has a tolling 
provision for minority, every State. This program, it's 3 years 
from the onset of symptoms. It doesn't matter if the parents 
didn't find out about the fact that the vaccine caused the 
injury. It doesn't matter that they didn't find out about the 
program until it's too late. They're out of luck.
    And you know what's even better? There is a vicious 
decision from the Federal Court of Appeals saying there is no 
equitable tolling in this program. There is no excuse for not 
filing on time.
    Now there's a case out of New Jersey, the McDonald case, 
saying, well, I'm sorry, if you didn't file in that program 
soon enough, then you can't file a State civil action either. 
So these kids cannot only not file in the program, they can't 
go file a civil action either, if the McDonald case holds up.
    This has got to be changed. There is a glaring inequity in 
the program, that if you do nothing else, change the statute of 
limitations to what every State in this Union allows. Any 
complaint, any objection to doing that has been answered by all 
50 State legislatures in the country. You can't say, well, the 
proof is going to go away. It's going to be hard to get 
evidence years later. If that's true, it works against the 
claimants, not against the respondent, because we have the 
burden of proof.
    You can't make any arguments against this. It's already 
been argued in all 50 legislatures, so do it.
    The second thing I've asked for is a different burden of 
proof. I would invite you to look at page 6 of my testimony, 
because the Chief Special Master has given you the language for 
legislation. He's a judge. He can't legislate. But in the 
Stephens case, which is on page 6, I point out what he is 
proposing as a burden of proof.
    Work with the Chief Special Master. He's a judge hearing 
these cases. He is inviting you. He is giving you this 
decision, saying, legislate it. I can't. It's right there.
    I was encouraged to be at the ACCV meeting chaired by Dr. 
Block on December 5th, and the American Academy of Pediatrics 
made a proposal about a new burden of proof which I thought was 
very promising, and I think Dr. Block will agree with that, 
that I think this is something where progress can be made.
    You have to understand, this compensation program is the 
model that is being used for distribution of funds, the 
September 11 funds. This is the program that is being used. I 
don't think it's going to be run the same way for that. I hope 
the lawyers up in the Eastern District of New York who are 
running this program and the Special Master that's been 
assigned to this is going to run it a little differently, but 
I'll be anxious to see what happens with that program.
    The third thing that I'm not even going to argue about, 
because nobody wants to hear a lawyer complain about fees. 
Nobody wants to hear it. I've written what I think about 
interim fees and costs. I don't care what you do with fees. You 
know, you can deal with my wife. She'll come up here and talk 
to you about fees. But cost, give us the cost to prosecute the 
cases.
    The chairman referred to thimerosal. The Institute of 
Medicine in Cambridge had a meeting, and they came back and 
said it's biologically plausible that thimerosal in these 
vaccines--and the amount was tremendous the kids were getting--
has caused neurodevelopmental disorders in some of these 
children. So it's biologically plausible. And they've 
recommended studies. Do you know how long it's going take to do 
those studies--2 to 5 years at a minimum.
    So don't put pressure on the Special Masters to rush me 
through the program. Don't focus on how long it takes to get 
through the program. Focus on the reasons why it takes time to 
get through the program. The reasons why these cases don't get 
through the program faster is because of the burden of proof, 
because we don't have interim fees and costs so we can 
prosecute the cases.
    If you want to make the system move smoothly, do those two 
things. If you want it to be fair to all people, pass that 
statute of limitations. Put it in there. It's got to be done.
    I would also like to say--I think it was Mr. Horn mentioned 
Tommy Sansone. Tommy Sansone's father is a New York City 
policeman. He has a private bill that's been on this Hill for 
some time. I would ask you to pass it. We represented the 
Sansone family. We've brought them up here. We've come to the 
Hill with him. When Moynihan was here, we were in his office. 
The Sansone bill needs to be passed. It's a private bill.
    I had a call today, this morning before I came here, from a 
lady down in the western part--I didn't even know we bordered 
Tennessee, but she's down close to Tennessee. And she said that 
she and six of her friends, nurses in a hospital, 6 years ago 
received hepatitis B vaccinations, all the same lot and 
everything else. There were seven of them. All seven of them 
developed MS-like disease. One of them recently died.
    Now, I intend to investigate that. If I have to find Erin 
Brockovich and make her work for free, we're going to 
investigate that and find out what happened out there.
    But there is a case where I have to say to her, ``ma'am, I 
can't bring your case in this program. Because in August 1997, 
hepatitis B vaccine was added to the program, and your case 
could have been filed, but it had to be filed before August 
1999. Sorry. It's too late.''
    I answer these questions every day.
    Thank you.
    Mr. Burton [presiding]. We are working on some legislation 
to try and correct some of those things right now. And 
regarding that private bill, I'll have to know more about that. 
They're very difficult to get passed, but we'll take a look at 
that.
    [The prepared statement of Mr. Shoemaker follows:]
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    Mr. Burton. Dr. Block.
    Dr. Block. Good afternoon, Mr. Chairman and members of the 
committee. I am delighted to have been invited here to discuss 
my observations as Chair of the Advisory Commission on 
Childhood Vaccines, on the National Vaccine Injury Compensation 
Program, and to offer observations regarding the effectiveness 
of the program. I would like to thank Chairman Burton and also 
Mr. Waxman for their continuing interest in the program and the 
health and welfare of our children.
    As a pediatrician, I provide care for patients and their 
families; and as the Chair of an academic department, I teach 
pediatrics to young physicians in training. I have personal 
vivid memories of watching children severely disabled or dying 
of diseases that are now preventable by vaccines. It is doubly 
difficult for me to watch today as a child suffers from one of 
those diseases, knowing that such suffering could have most 
likely been avoided.
    I appreciated your comments, Chairman Burton, when you said 
vaccines are important parts of our public health system and we 
want children to be protected against infectious diseases.
    Some will make the argument that vaccines exact a toll on 
children and, in rare instances, they do. Medicine cannot 
always be an exact science. There are no guarantees in 
medicine, just as there are no guarantees in life.
    Mr. Chairman, you also said in your opening remarks at the 
previous hearing that although the oral polio vaccine was a 
good public health tool in its time, it wasn't perfect. If 
perfection is to be our goal, no government program, no 
vaccine, no part of medical science will ever achieve that 
goal.
    I have no doubt that the establishment of the National 
Vaccine Injury Compensation Program was one of--if not the--
major reason that we generally have an adequate supply of 
vaccines today. There is no doubt in my mind that the program 
works well, but with some adversity or differences of opinion, 
especially in the non-table injury cases. However, I have been 
continually impressed over the last 3 years with the efforts of 
HHS and DOJ to decrease the adversarial process. I have seen a 
continuing effort to achieve that goal.
    At the last ACCV meeting, we had the opportunity to discuss 
two very pertinent topics related to this committee's concern 
that the program was too adversarial. The first was a proposal 
from the American Academy of Pediatrics on an alternative 
standard for adjudication of claims for non-table injuries. The 
second was a presentation by members of your staff on 
legislation that is currently being drafted. We were pleased to 
see that most of the recommendations that the ACCV made in 1999 
were included in the draft legislation. As former Chair of the 
ACCV, I hope that in the future the Commission can be a point 
of focus for discussions on vaccine-related issues, allowing 
the ACCV to collect the best information from which to advise 
the secretary.
    As a pediatrician, I envision the time when this program is 
not needed to the extent it is today. Because we might all 
agree, based on reliable data, that we have vaccines that have 
extremely rare adverse events and because we have a national 
health care system that provides adequate care for all of our 
disabled children, regardless of the cause of their disability.
    Speaking for myself, or having been spoken for, I think it 
is sad that a child allegedly injured by a vaccine can turn to 
this program for compensation, but a child injured by a 
vaccine-preventable disease may have little or no access to 
appropriate care and no source for financial resources to 
support that care.
    I have listened with concern to the stories told here today 
by parents who I don't believe represent the majority of 
parents who have dealt with the program but who have 
perceptions of their experiences we should not ignore.
    I watched video clips presented by your staff of similar 
parent presentations at the ACCV meeting last week. I find it 
difficult to respond to perceptions, when the actual facts of a 
case are not presented by both parties. But based on 3 years of 
experience with the ACCV, I do feel these cases, while 
compelling, are isolated, unusual and emotional representations 
of a definite minority of cases coming through the program. 
Based on my personal conversations with and reports presented 
to the ACCV by past and current parent members of the 
Commission and presentations by petitioners' attorneys and on 
data reviewed at each meeting by the ACCV, I believe the 
program works quickly and generously in most cases.
    I know that I speak not only for myself but also for the 
next Chair of the ACCV when I say that we welcome the 
opportunity to continue working with the public, with 
professional organizations and with Members of Congress to 
continuously improve the National Vaccine Injury Compensation 
Program and to ensure a safe future for our children.
    It is difficult, Mr. Chairman, to listen to accounts from 
parents whose lives and whose children's lives have been 
affected the way these parents today have had to experience and 
some of the parents that you listened to before. You share now 
a common experience with my everyday life, but the children 
that I hear about and care for are not vaccine injury children 
but are children with disabilities and other illnesses that 
have nothing to do with the purpose of today's hearing.
    I would go back to my statement that I am concerned that we 
have a program, maybe perhaps needing improvement, to help 
these families and would hope that some day we won't have to 
argue about these things because their needs would be covered 
by the same program that would cover all the children in this 
country.
    I want to thank you for the opportunity to express my views 
on the importance of the program and the ACCV and the critical 
roll they will continue to play in preserving the health of our 
children. More dialog with the ACCV will only benefit us all.
    I'll be happy to answer questions later.
    [The prepared statement of Dr. Block follows:]
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    Mr. Burton. Let me start off the question period by making 
a comment.
    I was never really too concerned about breast cancer until 
my wife became a victim, and she's very ill right now. And then 
you start looking into it, and you start realizing that things 
that could be done or should be done or haven't been done.
    My granddaughter received a hepatitis B shot, and within 3 
hours she quit breathing. She was rushed to the hospital, and 
my daughter gave her mouth-to-mouth resuscitation and, thank 
God, she survived. Now there are those who say that had nothing 
to do with the hepatitis B shot, but the people at the hospital 
truly believed it. It was a problem.
    My grandson--and I only have two grandchildren. My 
grandson, he received nine shots in 1 day, and we found out 
that the thimerosal that was in those shots included mercury, 
and within a very short time he became autistic, running around 
himself, banging his head against the wall, cupping his hand, 
screaming and hollering incessantly, and before that he was 
normal.
    Now, you know, there will be people who say those are just 
coincidences, but it happened to me personally, my 
granddaughter and my grandson.
    We used to have 1 out of every 10,000 children--and they 
could have been off in the statistics on that, it may have been 
1 in 9,000--but they estimated 1 in 10,000 children were 
autistic. But now it's fact--fact that 1 in 500 nationwide are 
autistic, and in some parts of the country--it approaches 1 in 
200 in the Northwest of this country. We've got data to prove 
that.
    Now when I listen to pediatricians and doctors who say, you 
know, we're doing everything that can be done and there's no 
indication that the vaccines are causing this. Then what is 
causing it? My grandson got about 50 times what the normal 
amount of mercury that a child would have or an adult would 
have in 1 day in nine shots, and he became autistic almost 
immediately. And yet, you know, the people at CDC and FDA and 
HHS all say, you know, there is nothing that can prove that. We 
can't prove that. But I can tell you, 1 in 500 kids nationally 
are autistic. You know, that is pretty bad when it used to be 1 
in 10,000. That is a pretty big increase, 20 times increase.
    So, you know, we have some real problems with that. And as 
I said before, I would say most doctors don't know thimerosal 
contains mercury, because the Capitol Hill physician, who is 
one of the finest men and nicest doctors I know, Admiral Issold 
over there, when I said, do you know that these vaccines have 
mercury in them? He says, no, they don't.
    And I said, look at this; and I got the insert out and 
showed him thimerosal. And thimerosal contains mercury as a 
preservative because they don't want to have single-shot vials. 
They put 10 shots in one vial. And the Members of Congress that 
are getting these shots don't even know it.
    And yet Canadians and scientists from around the world say 
and they showed us--we had a video here showing that the sleeve 
that surrounds the nerves in the brain are destroyed by the 
mercury immediately upon a very minute amount of mercury upon 
contact, and there are scientists all over the place that are 
saying that Alzheimer's and autism and other neurological 
disorders are being caused by the mercury and other substances 
that are in vaccines and that are in the environment.
    So, you know, we really need to take a close look at this. 
I'm not denigrating what you said. I'm just telling you that we 
need more research, No. 1.
    No. 2, there needs to be a more humanistic or humane 
attitude toward these people who are suffering like this. These 
people are really suffering. She lost her son, she went through 
all of this stuff, and yet when you get the CDC and the FDA and 
the Justice Department and they come up here, you know, I don't 
know how they defend this stuff.
    Now, let me ask you a few questions, because we've got some 
votes coming up here. After 8 years of fighting to get 
compensation, the Special Master ruled in your favor, Mrs. 
Barton, in 1999. At that point did the Justice Department ask 
that your lawyers agree not to--wanted you to agree not to have 
that published? That's what you said in your testimony.
    Mrs. Barton. Yes.
    Mr. Burton. Why do you think they did that?
    Mrs. Barton. They didn't want the case to be cited in any 
other cases, in any other people coming up----
    Mr. Burton. So they didn't want somebody with similar 
problems----
    Mrs. Barton. Right.
    Mr. Burton [continuing]. Being able to use that case as a 
basis for a claim?
    Mrs. Barton. Exactly.
    Mr. Burton. So they were blackjacking you?
    Mrs. Barton. Well, I called it extortion.
    Mr. Burton. Well, either way, blackjack, blackmail, 
extortion, it all amounts to the same thing.
    Mrs. Barton. Yes.
    Mr. Burton. Mr. Shoemaker, you're an attorney who 
represents lots of families in this program. What is the 
practical effect of a decision that goes against the government 
not being published?
    Mr. Shoemaker. Any unpublished decision cannot be used as 
precedent.
    Mr. Burton. So if you didn't agree to this condition, Mrs. 
Barton, and you insisted that the decision be published, the 
Justice Department would have said what?
    Mrs. Barton. Well, it was put to me through my attorney, 
Mr. Milmoe. The Justice Department attorney said that if I 
didn't agree to it being unpublished, that he would file 
another appeal.
    Mr. Burton. And drag it out?
    Mrs. Barton. And drag it out.
    Mr. Burton. And you were very sick at that point?
    Mrs. Barton. And he knew that.
    Mr. Burton. I see my time is expired.
    Do you gentlemen have questions at this time? Judge.
    Mr. Duncan. Yes.
    Mr. Burton. I'll have more questions later, and let me just 
say, Judge, before you start, we have about 11 minutes on the 
clock, and we'll go to 5 minutes, so we'll give you your time, 
and then we'll move.
    Mr. Duncan. OK. Thank you. Thank you, Mr. Chairman.
    Mr. Shoemaker, you heard Dr. Block say that it's his 
experience that this program has been very quick and generous. 
Has it been your experience that the program has operated very 
quickly? We have a staff memo here that says the program was 
intended to be less adversarial than civil litigation and was 
intended by Congress to compensate quickly, easily and with 
certainty and generosity, and yet all of these cases that I 
hear about, they seem to take several years. What is the 
average length of time and what has been your experience in all 
of these cases you've handled?
    Mr. Shoemaker. Let me repeat what I said. I don't think 
that the problem is a problem of delay. I think the problem is 
the reasons for the delay. In other words, if I am given the 
resources, if I am given interim fees and costs so I can 
finance these cases, so I can pay for things expeditiously, so 
I can hire the experts I need, I can move these cases through 
the system much more quickly.
    I tell all of my clients--for instance, hepatitis B 
clients, I tell them, look, here's the situation. If you want 
to go to a hearing right away, I'll take it to a hearing right 
away. But in my opinion, as the state of science is today, we 
have a good chance of losing.
    There are two things that have to come together for me to 
win a case. The science, the medical knowledge has to go up and 
reach a level where I have enough proof, and I'm trying to get 
Congress to reduce the burden of proof so that those two lines 
will cross sooner rather than later.
    Mr. Duncan. Let me ask you this. I was a plaintiff's trial 
lawyer and a judge before I came to Congress, and you know and 
I know that there are certain--there are some members of the 
profession out there who might take advantage of that if we had 
some sort of unlimited expense program. So have you come up 
with or could you come up with some type of recommendation on 
some type of expense-type program that you think would have 
some reasonable limitations on it? Or have you thought about 
that?
    Mr. Shoemaker. Yes, sir. As a matter of fact----
    Mr. Duncan. What have been your average expenses on one of 
these cases?
    Mr. Shoemaker. Expenses can vary, but they can certainly 
approach $5,000 to $10,000, and I'm not even doing the cases 
right. I mean, you've been a trial lawyer. You know how much a 
case can cost.
    Mr. Duncan. I know about that.
    Mr. Shoemaker. I know how much money I would like to spend 
on a case.
    Mr. Duncan. Have you made a recommendation?
    Mr. Shoemaker. I was just going to say Congressman Weldon 
had introduced a bill, H.R. 1287, which I think does address 
that issue, and I would encourage anybody to support H.R. 1287 
because it does all three things I talked about.
    Mr. Duncan. How do we strike the balance between, you know, 
what everybody says has been a very effective program and we 
don't want to scare people away from having their children 
vaccinated yet still educate the public? Because, as I said in 
my statement a while ago, it's a very sad thing that people 
take their children in for something that they think is good 
for them and then these things happen. And I think probably all 
three of these parents would tell you they had no idea. Did any 
of you have any idea that there would be adverse reactions when 
you took your children in?
    Mrs. Barton. Not at all. After the fact, I've done a lot of 
research on vaccine reactions, and there are some kids that are 
high risk for adverse reactions, and I think that certain--you 
know, that doctors definitely need to be aware of that 
especially.
    What scares me is when they do these big, you know, come to 
the mall and we'll vaccinate, you know, 200 children for free, 
and the doctors don't know these kids at all and don't know 
their medical histories.
    Mr. Duncan. Should we require that pediatricians give out 
understandable pamphlets after these shots are given, telling 
parents that if they see any of these symptoms that something 
should be done? Or what is being done?
    Mr. Shoemaker. Your Honor, that actually already is 
required. Dr. Block and I were talking about that earlier, that 
under the statute there is a provision that says that there's 
supposed to be forms developed that are supposed to be given to 
all the parents when their children are vaccinated. The form is 
supposed to advise as to the risks, the benefits and so forth. 
It's all supposed to say in there that there is this 
compensation program so that people would be made aware of the 
program. That's by statute. That's already in the program.
    Mr. Duncan. Is that a fairly new thing? Were all three of 
you given that information?
    Mr. Holder. Back when Brandon got his shot, all we got was 
that he might have a febrile seizure and he might be 
uncomfortable, to give him some Tylenol. I believe that things 
have changed, from what I understand, to what Mr. Shoemaker is 
saying.
    Mr. Shoemaker. Actually, it has been there since the 
beginning of this program, but the problem is there's no 
penalty for it. For failure to comply, there's nothing that 
says if a doctor doesn't do it, so what?
    And a lot of--as Dr. Block and I were talking about, a lot 
of doctors, you're dealing with a short period of time that 
you're dealing with a parent. You don't have a lot to do as a 
pediatrician. You know, if you go overboard on this thing, the 
fear is you're going to frighten parents. I mean, there are a 
lot of issues involved in this, as you know.
    But it is statutory right now. There is no penalty for 
failing to do it, but there is a statutory provision that says 
the Secretary is to develop these forms, and they are supposed 
to be handed out to the parents at the time, and I think they 
are even supposed to be signed. I'm not sure if the signature 
is required.
    Mrs. Barton. Can I make one comment----
    Mr. Duncan. Yes.
    Mrs. Barton [continuing]. To Dr. Block? You stated that 
there are kids out there with all these other diseases that, 
you know, that hopefully we'll be able to help pay for children 
with all diseases. This was something that was mandatory. This 
was something that we were forced to give our children. It's 
not like it was just a random luck or luck of the draw or a 
terrible tragedy that my child got this disease. Our children 
were forced to get these vaccines. So it's a little bit 
different than just a disease that would come about randomly. I 
believe it is, anyway.
    Mr. Duncan. Well, my time is up, and we've got to go vote, 
but I want to thank all of you for being here and this 
testimony you've given today.
    Mr. Weldon [presiding]. The Chair will now recess this 
hearing for approximately 10 minutes to give the members time 
to go vote and return.
    [Recess.]
    Mr. Burton [presiding]. The committee will reconvene and 
come to order. I want to apologize for the duration.
    Would the previous panel come back up--Mrs. Barton, Mrs. 
Dyer, Mr. Holder, Mr. Shoemaker, and Dr. Block.
    Let's get back to our questioning. Mr. Shoemaker, you've 
been a counselor for a long time on these kinds of problems. On 
Mrs. Barton's case, if they had appealed it and had not settled 
with her, based upon her not publishing the results, how much 
longer would that compensation have been delayed?
    Mr. Shoemaker. It could have been years. I mean, an appeal 
typically goes to the U.S. Court of Federal Claims, to a judge 
first, and then from there it would go on to the U.S. Court of 
Appeals for the Federal Circuit; so it could take a 
considerable period of time.
    Mr. Burton. So you think this was kind of a blackjack 
tactic that they used?
    Mr. Shoemaker. Well, I actually agree with Mr. Waxman in 
his comments, because he was saying the same thing that you're 
saying, that is, that we shouldn't have any unpublished 
decisions. It kind of reminds me of the Firestone tire 
situation, where for years plaintiffs' attorneys were settling 
those cases under seal so that they couldn't release----
    Mr. Burton. People were getting killed, yes.
    Mr. Shoemaker. That's exactly right. And I don't think 
we're dealing with the same thing here, but it's important for 
lawyers, like me, working in the program to have these 
precedents when they are favorable.
    I think also there's a digest of opinions that's used by 
the claims court that needs to be published on the Web site so 
that lawyers can easily research this area. There are a lot of 
lawyers out there around the country that maybe have one or two 
cases in the program. They can't possibly know what we know, 
representing hundreds of cases, and they need access to some 
research so they know what the law is.
    Mr. Burton. It's obvious why the Health and Justice 
Departments didn't want that published, because of that very 
reason.
    We received a letter last night from the Justice Department 
saying that in the Barton case it was in both parties' interest 
to have the case unpublished in lieu of appeal.
    What do you think about that argument?
    Mr. Shoemaker. You'd have to ask Ms. Barton.
    Mr. Burton. What do you think about that, Ms. Barton?
    Ms. Barton. Could you say that one more time?
    Mr. Burton. We received a letter last night from the 
Justice Department saying that, in your case, it was in both 
parties' interest, yours and the Government's, to have the case 
unpublished in lieu of appeal.
    What do you think about that?
    Ms. Barton. No. The only reason I agreed was just for the 
fact that----
    Mr. Burton. They pressured you?
    Ms. Barton [continuing]. That I needed to get it over with. 
I felt like I couldn't go through any more appeals.
    I mean, had we gone through more appeals, I'm sure that we 
would have won. It would have kept coming back in our favor. 
But I just didn't feel like I could keep going through it.
    So maybe they're saying it was in both parties' interest 
because of my illness, because I was sick. They're saying it 
was that it was in my best interest to not publish it because--
but still it goes back to their saying that they would appeal 
if I didn't.
    Mr. Burton. You don't agree?
    Ms. Barton. I don't agree, no.
    Mr. Burton. Mr. Shoemaker, has the Government ever employed 
this tactic with any of your other clients?
    Mr. Shoemaker. I can't think of that specific tactic. I had 
a situation one time where an attorney tried to tie my fees to 
a settlement, and I immediately expressed indignation; and when 
I did that, the attorney realized right away that it was 
inappropriate and, in fairness, backed off and said, no, that 
wasn't right.
    You have to understand that's not issue today too and this 
program--if I were only interested in making fees and making a 
living, I would rush these cases through the program. I 
wouldn't care if I won or lost because I'm going to get my fee 
and expenses anyway. But I can't live with myself if I do that, 
and that's one of the reasons why I want you to lower the 
burden of proof and give us the resources so that we can win 
these cases. Because, Congressman Burton, I want to assure you 
of something: The thrill of victory is never as great as the 
agony of defeat in these cases. It's not the same thing.
    Mr. Burton. Ms. Barton, how did you feel when your lawyer 
told you that you had to make this kind of a choice, either 
agree to not have it published or face appeal? What was your 
thought?
    Ms. Barton. It was agonizing. It made me feel, like I said, 
that I was being blackmailed; that I was--it was either, take 
the money and don't let anybody else ever be able to use this 
information again, or don't take the money and go through years 
and years more of appeals.
    Mr. Shoemaker. Chairman Burton.
    Mr. Burton. Yes, sir?
    Mr. Shoemaker. Could I just raise one issue. You had talked 
with Ms. Dyer about subpoenaing information about the numbers 
of doses per lot.
    Mr. Burton. In her case in Tennessee, right.
    Mr. Shoemaker. Right. And I think it's important to 
understand that we need that data in all cases because there's 
no way we can determine whether or not a case is a hot lot 
unless we know the denominator data. You may have one lot that 
has 10 reactions reported and another lot that has 100 
reactions reported; and that may be perfectly normal because 
the one lot may be 10 times as big, but we don't know that 
until we have the numbers of doses per lot.
    That information we've been trying to get for years. The 
manufacturers say it's proprietary, which I don't have any clue 
why. It doesn't make any sense----
    Mr. Burton. Let me ask Ms. Dyer, you did contact Merck 
about this?
    Ms. Dyer. I'm sorry. Say that again.
    Mr. Burton. No, it wasn't Merck. Who was it?
    Ms. Dyer. Lederle.
    Mr. Burton. Lederle. You did contact----
    Ms. Dyer. I gathered my information through the FDA Freedom 
of Information branch.
    Mr. Burton. I know. But did you contact Lederle about this?
    Ms. Dyer. No, I did not.
    Mr. Burton. Whom did you contact who said that this was 
proprietary and wouldn't give you that information?
    Ms. Dyer. I don't understand the question. I'm sorry. Who 
did I contact?
    Mr. Burton. You said that they wouldn't give you the 
information, and we said we'd subpoena the information on those 
lots.
    Ms. Dyer. Right. I was told by the FDA when I asked them 
how many shots come out of a bulk of vaccine, that that was 
confidential information.
    Mr. Burton. And they said they couldn't tell you?
    Ms. Dyer. Yes.
    Mr. Burton. I see.
    Ms. Barton. I was told by Lederle, and I asked the same 
question----
    Mr. Burton. And they said the same thing?
    Mrs. Barton. Yes, and----
    Mr. Burton. That sounds like both the FDA and the companies 
are trying to protect the company.
    Ms. Barton. What they said is that certain--you know, it 
just depends. Some lots will have 700 doses; some will have 
1,000; some will have--but it's confidential as to how many----
    Mr. Burton. No, I understand. I understand. But it sounds 
like the FDA is scratching the back--and that probably bothers 
them for me to say this--scratching the back of those 
pharmaceutical companies because they're concerned about the 
liability exposure.
    Mr. Shoemaker. Your Honor, there is actually information 
that--we know that the Government has this information because 
there was an article published, and I can provide that to you, 
which compared the two manufacturers of hepatitis B vaccine; 
and it stated that the one manufacturer had four times the rate 
of reactions as the other manufacturer.
    Interestingly enough, when you go back and look at the data 
that they submitted, when they were having them tested to 
approve the vaccines, that same pattern held true. The 
conclusion of the article was that, well, we don't know why 
this is, but it probably does not mean anything.
    Well, I think it means something if one vaccine 
manufacturer has a rate of reaction that's four times greater 
than another manufacturer; and to be able to publish that and 
state that, they had to know the numbers of doses per lot in 
order to make that calculation. So that information is 
available to the Government, not just the manufacturers.
    Mr. Burton. Well, why do you think that the FDA wouldn't 
allow a claimant to have information----
    Mr. Shoemaker. I think you can talk to NVIC. They have 
tried to get this information under the Freedom of Information 
Act. We've tried to get it. It's been----
    Mr. Burton. Well, what's your opinion?
    Why do you think they don't want to let it out?
    Mr. Shoemaker. I think because if you did it, you're 
probably going to find hot lots. You're probably going to find 
lots where----
    Mr. Burton. So why wouldn't you want the hot lots----
    Mr. Shoemaker. I think you want that information----
    Mr. Burton. I know, but why would the FDA and the 
manufacturer not want the hot lots revealed?
    Mr. Shoemaker. I don't know and I've been trying to figure 
out why that would be considered proprietary. I mean, it----
    Mr. Burton. No. But I mean, assuming that, take the 
proprietary out of it, why do you think they wouldn't want to 
know?
    Mr. Shoemaker. I can't speak for----
    Mr. Burton. You don't want to speculate about that?
    Well, I'll speculate on it.
    Ms. Barton. I think they wouldn't want any more claims----
    Mr. Burton. Lawsuits or many claims.
    Ms. Barton. Right.
    Mr. Burton. Right. I think that's exactly right, and I've 
had a suspicion for a long time that a lot of the people that 
work at FDA and HHS have direct or indirect ties with 
pharmaceutical companies, and they protect them; and it's 
really sad.
    And when we look at the financial disclosure forms, we have 
found people on the advisory committees that make 
recommendations to the FDA on drugs being put on the market for 
vaccination purposes. We have found conflicts of interest. What 
was that vaccine we had?
    The RotaShield vaccine, the chairman of that advisory 
committee had stock in a company that was working on the 
RotaShield virus, a vaccine. And they brought in three people 
from the FDA, or four people, to vote on that because they 
didn't have a quorum present; and they urged them to vote for 
it, and within a year children had died. There had been all 
kinds of problems with it, and it had not been properly tested 
even though there had been concerns--some concerns about it at 
the advisory committee meeting. But it looked like, because the 
chairman was recommending it, they went ahead with it. And he 
had a financial interest. That's sad.
    And this brings up a question about these other things like 
this, these hot lots and the statistical information we'd like 
to have, because it sounds like, because of this arrangement, 
that there are people at the FDA that are trying to protect 
interests that they may have with pharmaceutical companies, 
either prospective or in the past. They may have worked for a 
pharmaceutical company or they anticipate working for one or 
they get benefits from them in one way or the other.
    And some people may say, that really is a pretty serious 
charge to level, but I will tell you, I have a lot of friends 
who are doctors, and it's a constant thing for the 
pharmaceutical companies to be spending a great deal of money 
taking people out and wining them and dining them, who are in 
governmental agencies, taking them on trips, as well as the 
doctors themselves who use those products. And so there's a 
real interplay there that I think does a disservice to the 
American people, and that's one of the reasons why we're going 
to have probably about 14 or 15 of these hearings in the next 
year, and the FDA is going to be over here listening to this 
and asking questions about it.
    Mr. Shoemaker. When you have a couple hours for me to talk 
about flu vaccine, I'd be glad to----
    Mr. Burton. I'll get back to you on that because those of 
us who were concerned with the anthrax threat--and all of our 
mail has been taken away from us; we haven't had mail in the 
Capitol for 6 weeks now, 7 weeks, and it's because of the 
anthrax scare. So we have been told that we should all get a 
vaccine for--the flu vaccine because the threat is there that 
we may be exposed to anthrax. And it looks like the flu, and so 
we have to be able to protect ourselves against the flu so 
we'll know what it is if it hits; and so we're all forced to 
take the vaccine in the form of a shot, and every one of us is 
getting thimerosal or mercury in that vaccine. We don't have 
any choice.
    And most of the doctors, as I've said, don't even know 
what's in there.
    Let me get back to the questions here. Let me go to Ms. 
Dyer.
    When Andy and your other children were vaccinated, did your 
doctor or the nurse tell you there was a chance there would be 
an adverse reaction and how to recognize it?
    Ms. Dyer. Before we recessed I wanted to say yes, I was 
given the pamphlet that lists reactions. I don't remember the 
exact numbers, but a one-in-so-many-thousand chance of death, 
one-in-so-many-thousand chance of seizure.
    The thing that I disagree with is the fact that a lot of 
these symptoms appear to be non-life-threatening. Parents, 
unless you have a child who has a seizure or you know somebody 
with a seizure disorder, I don't think that a lot of people 
realize that just a stare off into one direction could be a 
seizure, this right here, which is what my son started doing--
--
    Mr. Burton. You didn't recognize that as a problem?
    Ms. Dyer. You don't recognize that as a seizure--or the 
doctors----
    Ms. Barton. Or the shivers that I said my son was having at 
night.
    Ms. Dyer. They tell you that a child being sleepy is 
normal.
    Mr. Burton. Let me ask you, were you asked to sign a form 
stating that you'd been told your child might have an adverse 
reaction?
    Ms. Dyer. Yes.
    Mr. Burton. But you thought it would be a minor thing?
    Ms. Dyer. Seizure, death, swelling at the injectionsite----
    Mr. Burton. So you were aware of that?
    Ms. Dyer [continuing]. Fever. Yes.
    Mr. Burton. OK. In your testimony you stated that your 
petition for compensation for your child's vaccine injury was 
rejected in 1999.
    How do you provide for his care now? How do you take care 
of the financial requirements?
    Ms. Dyer. It's difficult. We have parents that live nearby 
that help us out quite a bit. My husband is self-employed, and 
because of Andy's injury, I can't really work outside the home. 
We have a church family that helps provide a lot of financial 
assistance when we need it.
    Mr. Burton. But you have an unusual financial burden 
because of that?
    Ms. Dyer. Yes, sir.
    Mr. Burton. How much extra does it cost to care for Andy 
each year over that of your other kids?
    Ms. Dyer. With therapies and extra things that he needs 
that his insurance does not cover, I would guess as much as 
$9,000 to $10,000 a year.
    Mr. Burton. Really?
    Did you find out about the number of adverse events 
reported in that lot of vaccine that Andy received?
    Ms. Dyer. I contacted the FDA Freedom of Information branch 
and----
    Mr. Burton. So you only got it from the FOA, Freedom of--or 
FOI?
    Ms. Dyer. Right. And after 2 years and during those 2 years 
never being told that there was a relationship, a friend of 
mine mentioned that she had seen a show on the vaccine and the 
shots; and so I called his physician and got the information as 
far as the drug company name and lot number and called the FDA.
    Now, when I called the FDA, you were mentioning about how 
maybe they were scratching each other's back. I felt really put 
off. They asked me why I needed that information, has your son 
already been vaccinated?
    Well, if he's already been vaccinated, you don't need that 
information. They did not want to give it to me freely. I mean, 
I had to fight for it.
    Mr. Burton. Are you aware of whether the FDA ever contacted 
Lederle about this hot lot, or if they were ever found to be in 
violation of good manufacturing practices regarding this 
product?
    Ms. Dyer. Not to my knowledge.
    Mr. Burton. So you don't know if this hot lot--where they 
had all of these adverse reactions, if the FDA even contacted 
Lederle?
    Ms. Dyer. Not to my knowledge.
    Mr. Burton. I want to subpoena any records that the FDA has 
regarding Lederle and this hot lot. I want to get the hot lot 
number, and I want to send a subpoena over to the FDA regarding 
any correspondence between them and Lederle regarding that.
    Ms. Barton. I know that Dateline did a show that was 
completely about hot lots on DPT vaccines.
    Mr. Burton. I understand that, but the point is----
    Ms. Barton. I'm just saying that they talked with the FDA 
and Lederle. So they did a show completely about the hot lots 
and certain ones. I don't know if yours was one of them.
    Ms. Dyer. Mine was not one of those.
    Mr. Burton. Well, in any event, was all that information 
exposed in that television show?
    Ms. Barton. Not the number of doses, but the hot lots were 
there.
    Mr. Burton. Well, what we want to find out is the number 
of----
    Ms. Barton. Is the number of doses, right.
    Mr. Burton. What we want to find out is the number of 
doses, the number of adverse reactions, whether or not there 
was any correspondence between Lederle and the FDA; and if so, 
we want to see it. OK?
    What's the long-term prognosis--I need you to pay attention 
to me now because we've to get through a lot of work here. I've 
got these people from the FDA and the Justice Department that 
are going to have to testify.
    What is the long-term prognosis ran for Andy?
    Ms. Dyer. Andy's condition right now, he's severely 
developmentally delayed. Mentally, he's at an 18-month-old 
level.
    Mr. Burton. How old is he?
    Ms. Dyer. He's 9.
    Mr. Burton. He's 9 and he has an 18-month-old----
    Ms. Dyer. He's at an 18-month-old level, mentally. 
Physically, he is very strong. He's able to crawl on all fours 
and actually able to pull himself to a stand, but he will never 
be a normal child. He will always require assistance in 
everything that he does.
    Mr. Burton. And I'm sure you worry about what's going to 
happen when he gets older and you get older.
    Ms. Dyer. Yes, sir. He's 9 years old and weighs 100 pounds 
now, so----
    Mr. Burton. I understand.
    Ms. Dyer [continuing]. He's a big boy.
    Mr. Burton. Mr. Holder, we haven't asked you a great many 
questions about your situation. Would you like to expand and 
expound on that a little bit before we change to the next 
panel?
    Mr. Holder. Were there any specific questions you had?
    Mr. Burton. Well, you heard the kind of problems that Ms. 
Barton and Ms. Dyer had. Do you have any comments regarding the 
way--I know you mentioned the State in which you live is not 
living up to the same standards that other States are, or the 
Federal Government.
    Mr. Holder. Well, no. See, I understand more now and speak 
to Mr. Balbier that--and I did understand before that the State 
laws are really trying to protect the interests of the child, 
but I think my point of contention with that was that you were 
awarded money for specific things, but yet you still had to go 
through the State again; and with Brandon's disability and a 
job and it's just very hard to try to fight for all of the 
things that were already promised, once again.
    Mr. Burton. But you did get a settlement?
    Mr. Holder. Yes.
    Mr. Burton. And you're not dissatisfied with the way you 
were handled?
    Mr. Holder. I am dissatisfied with the length of time that 
it took to settle the case. It was a total of 6 years that it 
took for----
    Mr. Burton. And during that time you had to have an 
attorney, you had to pay expenses and all that sort thing, and 
it was a real burden on the family?
    Mr. Holder. Yes, very much a burden. And again----
    Mr. Burton. Did you recoup any of those moneys that you 
spent during that 6 years?
    Mr. Holder. Yes. Those moneys for unreimbursed medical and 
any legal were reimbursed through the lump sum.
    The most important thing about the length of time, to me, 
is the impact it has on the child, the additional therapies, 
professional help, these quality cares that he could have been 
getting all along were not gotten. And my point with that is, I 
don't know if it would have made him better, but I never will 
know if it would have improved----
    Mr. Burton. So if they had moved quicker, you think he 
might have gotten additional treatment that would have helped?
    Mr. Holder. Absolutely. I believe that to the bone, yes.
    Mr. Burton. I think that's an important point that we need 
to look at too.
    Anything else I need to--oh, yes, Dr. Block----
    Mr. Holder. There was also--oh, I'm sorry.
    Mr. Burton. Go ahead. Sure.
    Mr. Holder. There was also--in 1998 they did an MRI, and 
there was a shadow. And the doctor clearly stated on the bottom 
that this shadow was because the child had turned his head. And 
the Special Master had tried to just throw it out based on 
that, immediately had it dismissed; and we had to run and get 
the records and say, you know, look, it says this. But they did 
try to throw it out because----
    Mr. Burton. There was a shadow where, on his brain?
    Mr. Holder. The shadow--yeah, in the MRI. And the doctor 
who read it clearly stated, this is because the child moves; 
and he was shaking his head, and they--it seemed as if they 
just chose to ignore that little part and----
    Mr. Burton. So the constant shaking of his head was causing 
additional damage; is what they were saying?
    Mr. Holder. I'm sorry?
    Mr. Burton. The shaking of his head was causing damage or--
--
    Mr. Holder. No, no. He was saying the shadow that was 
showing on his MRI was because he had moved his head during the 
MRI----
    Mr. Burton. Oh, I see.
    Mr. Holder [continuing]. And the interpretation of the 
defense was, oh, they looked at the MRI and they said 
``shadow,'' but they omitted the part that the doctor said it 
was because he had moved his head toward it, trying to get the 
case dismissed.
    So that--to me, that is an example of being adversarial and 
not, you know, having the full information and trying to have 
it tossed out because of this.
    Mr. Burton. But finally you did get restitution?
    Mr. Holder. Well, yes, sir. Absolutely.
    Mr. Burton. OK. So your main concern is that it took too 
long?
    Mr. Holder. It took too long, correct.
    Mr. Burton. Dr. Block, do you have any opinion on whether 
the nonpublication of decisions is appropriate?
    Dr. Block. No, sir. I don't understand that legal 
implication at all.
    Mr. Burton. Do you think they should be published?
    Dr. Block. I don't know what the legal standards would be 
for that. I would probably have to defer to my lawyer friends 
for that.
    Mr. Burton. I know, but you're a doctor and you're a 
pediatrician. Ms. Barton, she was told they would settle her 
claim if they didn't publish this.
    As a pediatrician knowing the kind of problem that she had, 
do you believe that should be published?
    Dr. Block. Well, Mr. Chairman, it's very, very hard to give 
a specific answer to a case, when I don't know the details, and 
to offer a legal opinion. In science, we think all facts should 
be before everybody. Whether that's true in the legal arena or 
not, I just don't know, but it certainly would be true in 
science.
    Mr. Burton. Thank you.
    Well, I want to thank you very, very much. I hope you'll 
stay around for just a little bit because we're going to have 
the people from the agencies involved to testify now and ask 
them some questions, and it might be of interest to you and 
help us in the future.
    The next panel, we would like to come forward now. Mr. 
Balbier, Mr. Harris, Mr. Euler, would you please stand so we 
can have you sworn, please.
    [Witnesses sworn.]
    Mr. Burton. I appreciate your being so patient today. I'm 
sorry we have had so doggone many votes.
    Do any of you have an opening statement you want to make?
    Mr. Balbier, do you have an opening statement?
    Mr. Balbier. Yes, I do.
    Mr. Burton. OK.

  STATEMENTS OF THOMAS E. BALBIER, JR., DIRECTOR, DIVISION OF 
VACCINE INJURY COMPENSATION, OFFICE OF SPECIAL PROGRAMS, HEALTH 
   RESOURCES AND SERVICES ADMINISTRATION, U.S. DEPARTMENT OF 
    HEALTH AND HUMAN SERVICES; PAUL CLINTON HARRIS, DEPUTY 
ASSISTANT ATTORNEY GENERAL, CIVIL DIVISION, U.S. DEPARTMENT OF 
 JUSTICE, CONCERNING THE NATIONAL VACCINE INJURY COMPENSATION 
  PROGRAM; AND JOHN EULER, DIRECTOR, NATIONAL VACCINE INJURY 
        COMPENSATION PROGRAM, U.S. DEPARTMENT OF JUSTICE

    Mr. Balbier. Good afternoon, Mr. Chairman and members of 
the committee. I'm pleased to be here this afternoon to talk to 
you about the National Vaccine Injury Compensation Program. 
And, first, I would like to thank the members of this committee 
and Chairman Burton, Representative Waxman, and Dr. Weldon in 
particular for your interest in the program and your 
participation in our ongoing efforts to improve the program.
    The Department of Health and Human Services is committed to 
making this program more expeditious and less adversarial. I am 
very encouraged by the recent developments toward this common 
goal that have taken place.
    At the committee's last hearing on November 1, I was asked 
if I would be willing to work with this committee and its staff 
to craft legislation aimed at improving the operation of the 
program that could receive broad consensus for approval within 
the legislative and executive branches of government. In 
response to that request, I can report that substantial 
progress already has been made due to extensive cooperation 
with committee staff.
    On November 19, the chairman of the Advisory Commission on 
Childhood Vaccines wrote a letter to invite Chairman Burton and 
Representative Waxman, or your staffs, to the ACCV's December 5 
meeting to present Chairman Burton's newly drafted legislative 
proposal to make improvements to the program. Both of you 
accepted this invitation and sent your staffs to the ACCV 
meeting to discuss your proposed legislation. I would like to 
thank Chairman Burton and Representative Waxman for allowing 
your staff to take time out of their busy schedules to present 
this draft bill at the ACCV meeting.
    The ACCV is comprised of nine voting members including 
three medical professionals, three attorneys and three members 
of the general public. Two of the medical professional members 
are required to have expertise in pediatrics; one of the 
attorneys is required to represent claimants under the program 
and one attorney is required to represent a vaccine company. Of 
the general public members, two are required to be parents of 
children injured by the very rare but serious adverse reactions 
to childhood vaccines.
    Many of the provisions in Chairman Burton's draft bill are 
the same as those proposed by HHS in its proposed amendments 
sent to Congress in June 1999, but never introduced as a bill. 
These proposals were developed based on strong consensus 
recommendations of the ACCV and enjoy the support of the 
current administration.
    We are looking forward to working very closely with 
Chairman Burton, Representative Waxman, the Department of 
Justice, and the ACCV to make needed improvements to the 
National Vaccine Injury Compensation Program.
    I'll be pleased to answer any additional questions you may 
have. Thank you.
    Mr. Burton. Thank you, Mr. Balbier.
    [The prepared statement of Mr. Balbier follows:]
    [GRAPHIC] [TIFF OMITTED] T7527.128
    
    [GRAPHIC] [TIFF OMITTED] T7527.129
    
    [GRAPHIC] [TIFF OMITTED] T7527.130
    
    Mr. Burton. Mr. Harris, do you have an opening statement?
    Mr. Harris. Yes, sir.
    Mr. Burton. OK.
    Mr. Harris. Good afternoon, Chairman Burton, Ranking 
Minority Member Waxman, members of this committee. Thank you 
for the opportunity again to appear before you to talk about 
the Vaccine Injury Compensation Program. With me this afternoon 
is John Euler, Acting Director of the Torts Branch, which 
oversees the vaccine litigation group. So that I may limit my 
remarks this afternoon and allow more time for discussion and 
questions, I request that my full written statement be entered 
into the record.
    In the face of such traumatic personal tragedies as those 
described by members of the preceding panel, Justice Department 
lawyers, along with officials from the Department of Health and 
Human Services, face the daunting responsibility of carrying 
out congressional intent as we implement the statute and uphold 
the provisions of the Vaccine Injury Compensation Act. Each 
claim under the program has its own personal story.
    The cases very often involve complex legal and medical 
issues, but are always overlaid with heavy emotions. 
Nevertheless, we endeavor to exercise our responsibility with 
the highest degree of professionalism and with the goal that 
each case is handled in the most efficient and fair manner 
possible.
    To attain this goal, we have been and remain firmly 
committed to working with the Congress, HHS, the court and 
other interested groups, such as the Advisory Commission on 
Childhood Vaccines and petitioners' bar to make this program 
the best that it can be. Indeed there are encouraging examples 
of positive developments in the program.
    Today a greater percentage of families is compensated than 
in the early years of the program's existence. In each of the 
past 5 years between 41 percent and 54 percent almost half of 
all cases adjudicated have resulted in compensation for 
claimants.
    In contrast, from 1991 to 1996, fewer than one-third of the 
cases adjudicated each year were compensated and the other 70 
percent were dismissed.
    In addition, we have increased our use of alternative 
dispute resolution threefold in just the 2 years alone in an 
effort to resolve more cases informally without the need for 
court hearings. Furthermore, one of our attorneys recently 
organized a working group in coordination with the Office of 
Special Masters. The working group includes Special Masters, 
claimants' attorneys, a parent, Justice Department attorneys 
and HHS staff. This group will reevaluate and revise the 
guidelines for practice under the Vaccine Injury Compensation 
Program with the goal of devising procedures to further 
expedite case processing. In particular, the group intends to 
focus on the process of settling the damages portion of these 
cases, which is often shown to be a very time-consuming aspect 
of program cases.
    We do recognize this committee's oversight responsibilities 
and indeed appreciate your commitment to ensuring that the 
program operates fairly and in accordance with congressional 
objectives. Again, we are pleased to work with the committee 
and to assist you in carrying out these responsibilities.
    I would like to remark on the concerns and issues raised by 
the witnesses on the panel that preceded me. At the Justice 
Department we, too, are concerned by comments from individuals 
such as those who testified today that indicate that the 
program has become too adversarial. We are also concerned by 
examples of cases that have taken too long to process.
    Having resolved more than 5,400 cases since the inception 
of the program, we acknowledge that some cases indeed have not 
been processed as efficiently as possible. Of course, the most 
difficult aspect of each individual case is that it involves a 
person, usually a child, with serious health conditions. 
Indeed, many of us at the Department are parents ourselves and 
therefore feel tremendous empathy and compassion for each 
claimant and for their family as well. We know and appreciate 
the suffering they endure.
    Regardless of the cause, childhood disease and injury are 
always tragic. Regrettably, whether a family receives a prompt 
compensation or whether the case is dismissed because the 
injury is found to be unrelated to vaccine, this program simply 
cannot reverse the family's tragedy or eliminate the inevitable 
sadness, pain, or anger they understandably experience.
    Like all cases filed under the program, the three cases 
described this afternoon are obviously very difficult to hear 
about. We understand that these claimants are disappointed with 
the process and, indeed, we regret that their experiences were 
not more positive. It is important to hear concerns like the 
ones that have been expressed today so that we may hope to 
improve the program where it is possible to do so. Indeed, I 
have required our attorneys to either review the transcript or 
view a videotape of these proceedings.
    I trust that the committee also has reached out to hear 
from families and practitioners that are pleased with the 
program. Certainly it would be unfair to the public to leave 
the impression that all, or even most, of the families have had 
bad experiences with the program. I understand that the 
committee has heard complaints from many individuals that your 
staff has spoken to. But I also know that there are many 
satisfied program participants as well.
    I would like to comment briefly on some of the remarks made 
from the preceding panel beginning with Ms. Barton's statement 
regarding her son Dustin's case. I understand that Ms. Barton 
is very disappointed with her experience in the program. In 
fact, we too agree that a case should not take 8 years to 
process.
    This is not something I came here to defend. Fortunately, 
the vast majority of cases are handled in far less time. To be 
sure, the average time for processing newly filed petitions is 
2 years. Dustin's case was exceedingly complex medically and 
procedurally, which resulted in significant delay.
    As an example, the medical records did not support Ms. 
Barton's initial claims that the vaccine was the cause of 
Dustin's injury. This made the case difficult from a factual 
perspective. From a medical standpoint, Dustin suffered from 
significant structural brain abnormalities which were present 
before he received his immunization and were known to cause the 
type of neurological problems he suffered.
    This case was also complicated by the fact of Dustin's 
unfortunate and unexpected death in 1997, therefore changing 
the situation from an injury case to a death case. Finally, as 
the Special Master's decision acknowledged, ``This case met 
with agonizing delays. The parties had difficulties in 
obtaining the required expert reports and critical autopsy 
materials including slides of the brain needed for expert 
analysis.''
    All parties would have liked for this case to have been 
processed more quickly than it was. I can assure you and this 
committee, Mr. Chairman, however, that there was never any 
intentional delay or neglect by the Department, nor do I 
believe that it is appropriate to place blame on any of the 
parties for the length of time it took.
    Ms. Barton stated that she was treated unkindly by the 
Department attorney who handled her case. We absolutely do not 
condone disrespectful treatment of claimants, their families, 
or any other program participants. We regret that her 
experience with the program caused her further anguish.
    I understand that at the hearing very sensitive personal 
and medical matters needed to be explored to best understand 
the likely cause of Dustin's condition. While I cannot discuss 
these matters in further detail, I can understand that it was 
difficult for all parties to address them.
    Ms. Barton stated that she was required to agree to have 
her decision designated as unpublished in order that the 
Government agree not to appeal her case. I would like to advise 
the committee that in every case the final determination of 
whether a vaccine in that case will be published or unpublished 
rests with the presiding Special Master.
    The Government has occasionally sought petitioner's 
agreement to jointly request that a Special Master-designated 
decision is not published with the understanding that the 
Government would not appeal the decision. Those situations 
arise when we are concerned that an erroneous decision may 
adversely impact the program but do not believe that further 
litigation is appropriate given the circumstances of each 
individual case.
    In some situations, we determine that the interest of all 
parties may be best served by our agreement to forgo appeal and 
further litigation and further delay so long as the decision is 
not published. That was the situation in this case. Although we 
disagreed with the Special Master's evaluation of the factual 
and medical evidence and believe that the child's condition and 
tragic death were caused by a pariventricular leukomalacia 
[PVL], a condition he was unfortunately born with, we agreed to 
compensate this case without further litigation if it would be 
designated unpublished. Ms. Barton's attorney then joined us in 
making that request of the Special Master.
    Turning to the case involving Ms. Dyer's son, Andy, I 
understand that Ms. Dyer was also happy with her experience 
under the problem. There were two significant issues that 
complicated this case. First, the claimants required almost 3 
years to submit the necessary medical reports and expert report 
and second, the medical records did not support a finding that 
Andy suffered a table injury.
    This case illustrates perhaps the most common reason for 
case delay, the difficulty in acquiring and producing medical 
records and an expert report. There were 15 court orders in 
this case setting and resetting the deadline for the Dyers to 
provide these documents.
    I can assure the committee that the Department did what it 
could to contribute to swift processing of this case. For 
example, our initial report was submitted within the 90-day 
time period established by the courts. We filed our expert 
report just 3 weeks after the Dyers filed their report, and the 
hearing was held 1 week later.
    Understandably, Ms. Dyer was disappointed with the outcome 
of the hearing. Although the Special Master heard the Dyers' 
testimony, she concluded that the medical records were more 
persuasive evidence of the events that occurred at the time of 
the vaccination. The Special Master was convinced, as the 
medical records indicated, that Andy's condition began over 3 
weeks after his DPT vaccination and, importantly, was unrelated 
to it.
    The Special Master's decision to credit the medical records 
over the Dyer testimony is based on well-established case law, 
which explains the principle that, ``oral testimony which is in 
conflict with the contemporaneous documents is entitled to 
little evidentiary weight.''
    Of course, one role of the Special Master is to resolve 
difficult factual discrepancies, such as existed in this case, 
and therefore it is not unusual for a Special Master to rely 
upon medical records which were prepared by a physician at the 
time the events are occurring.
    Finally, I would like to address Jim Holder's comments 
about his son Brandon's case. Like the other children described 
today, Brandon too, unfortunately, suffered a seizure disorder. 
One significant issue affecting the processing of this case was 
evidencing the medical record of a factor unrelated to the 
vaccine which might explain Brandon's seizure disorder. 
However, after the submission of additional documentation, the 
government conceded Brandon's entitlement to compensation. The 
claimants required over a year to submit a life care plan and 
another 6 months to submit supporting documentation. 
Ultimately, the parties cooperated in negotiating and agreeing 
upon a life care plan and the Special Master issued a decision 
based on this plan.
    Mr. Holder testified that it took him a long time to find 
an attorney to represent him. We are sympathetic to the 
difficulty of finding an attorney. Oftentimes a family's 
experience with the program is the first time they have had to 
work with a lawyer. To help eliminate the challenge of finding 
an attorney, the Court of Federal Claims recently compiled a 
list of more than 100 attorneys from around the country willing 
to represent vaccine act claimants. We are also pleased to 
report that nearly 250 attorneys clearly represent claimants in 
pending cases. Moreover, the program's outreach efforts have 
increased substantially in recent years.
    As I stated before, many of the claims under the program 
often involve complex legal and medical issues, which are 
compounded by a heavy emotional element. Nevertheless, I can 
assure this committee that our attorneys endeavor to exercise 
our responsibility to each claimant, to the families involved 
and to the goals of this program with the highest degree of 
professionalism, with the ultimate objective that each case is 
handled in the most efficient and fair manner possible.
    Mr. Chairman, again I thank you and members of this 
committee for allowing me this opportunity to appear before you 
again today, and I want to in closing assure the committee that 
we hear what you're saying about the need to have compassion in 
this program. It is something that I am certainly driving home 
with the ones that work in the program. It is something that I 
will certainly share with my superiors back at the Department 
of Justice.
    Thank you.
    [The prepared statement of Mr. Harris follows:]
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    Mr. Burton. Thank you, Mr. Harris. Mr. Euler, do you have a 
comment?
    Mr. Euler. I have no opening statement, Mr. Chairman.
    Mr. Burton. Thank you. Do you think that the results of 
these settlements in these cases should be published, Mr. 
Harris? If not, why?
    Mr. Harris. The unpublished situations occur when there is 
an issue of whether we are going to appeal or not appeal, and 
these decisions are not sealed, as has been previously 
described. The effect of an unpublished decision basically 
relates to a lawyer's ability to cite a case as a credible 
reference in future cases. In the case of the Special Master, 
unpublished decisions just simply would not appear on Westlaw. 
That is the effect of having unpublished----
    Mr. Burton. Well, if you settle----
    Mr. Harris [continuing]. Opinions.
    Mr. Burton. If you settle a case, like you did in the one 
we're referring to, the Barton case, why would you object to 
having that published?
    Mr. Harris. The----
    Mr. Burton. Because according to her, Mrs. Barton, the 
settlement was based upon it not being published, and if she 
insisted on it being published, there would be an appeal. So 
why shouldn't that be published?
    Mr. Harris. We didn't think the case should be published 
because we thought that the Special Master's decision in the 
case was erroneous.
    Mr. Burton. Well, then why did you settle?
    Mr. Harris. Because we have to weigh competing interests 
here. We can't further litigate an appeal on the one hand and 
drag this case out even more.
    Mr. Burton. Had you not lost one appeal on this, in that 
case? Didn't you lose an appeal on the Barton case initially?
    Mr. Harris. The case was we handled, if I recall, 
correctly.
    Mr. Euler. There was a motion for reconsideration in the 
case, which the Special Master did hear, short of the time, and 
as she mentioned, per opinion that we filed before the appeal 
period had come. So she did reconsider the case and then issued 
another decision which was published at the time.
    Mr. Burton. And that decision was?
    Mr. Euler. The decision was to compensate.
    Mr. Burton. OK. So the first decision was to compensate, 
and then there was a second decision to compensate?
    Mr. Euler. That's correct.
    Mr. Burton. And then you guys decided, the Justice 
Department, to appeal it. But you said rather than appeal it 
and fight this out, if you don't publish this, we'll settle it. 
Is that right?
    Mr. Euler. Well, we didn't--we said we think this case--
well, we were told by our medical adviser that this case is 
wrongly decided and may have programmatic impact. There is a 
problem----
    Mr. Burton. Let's take that one step at a time. It would 
have a programmatic impact.
    Mr. Euler. Yes, sir.
    Mr. Burton. Which means that in layman's language, if that 
had been published, it would probably increase the amount of 
litigation in those kinds of cases, right, and it might 
adversely affect the program?
    Mr. Euler. It might--that's right. We take very seriously 
the scientific integrity of the program.
    Mr. Burton. Well, what about the Special Master? The 
Special Master made the decision it should be compensated not 
once but twice, and evidently the Special Master, who has legal 
standing and who also had all the facts in the case concerning 
the medical records and everything, I assume they talk to 
experts, the Special Master talked to some experts before he 
made her, or she made her decision. But you talked to a 
different medical expert that didn't agree and so you decided 
not to appeal it because you're good-hearted?
    Mr. Euler. There are competing interests, as Mr. Harris 
said. On the one hand, you've got a decision that we think is 
wrong. On the other hand, we're trying to expeditiously resolve 
the case so that there isn't further litigation and the 
petitioner gets paid.
    Mr. Gilman. Would the chairman yield?
    Mr. Burton. I'll be happy to yield.
    Mr. Gilman. I don't understand withholding erroneous--what 
you consider to be erroneous decisions from publication. Is 
this a common practice in your department?
    Mr. Euler. It is not. From what we can tell, we've had 
agreements not to publish a case perhaps once or twice a year.
    Mr. Gilman. How many cases have been withheld from 
publication?
    Mr. Euler. We don't know the answer to that. I suspect it 
would be 8 or 10.
    Mr. Gilman. And does the Department of Justice approve that 
kind of withholding of information to the public?
    Mr. Euler. First off, it's not withheld except in the sense 
that it is not published in Westlaw, but----
    Mr. Gilman. That is withholding it from the public, is it 
not?
    Mr. Euler. It cannot be cited. Petitioners are free to 
circulate the decision. It is not sealed. It is not kept 
secret. Petitioners can in fact do what they will with the 
decision. We don't seal settlements. What this is is----
    Mr. Gilman. Well, except when you tell them that part of 
the agreement on settlement is they're not to publicize the 
settlement and the basis for it.
    Mr. Euler. We do that as a way to try to expedite the case, 
and we suggest that it's in both parties' interest. It's in our 
interest not to have the case published. It's in their interest 
to be done with the--it's in everybody's interest to be done 
with the litigation, and this was a tool to try to resolve 
the----
    Mr. Gilman. And has the Justice Department approved that 
kind of procedure?
    Mr. Euler. Yes.
    Mr. Burton. Let me ask you a question. Why was this in Mrs. 
Block's interest that not be published?
    Mr. Euler. It was in her interest----
    Mr. Burton. Why was it in her interest to not have it 
published?
    Mr. Euler. So that the litigation would not continue, so we 
can get her the money?
    Mr. Burton. Oh, so you said to her----
    Mr. Euler. I did not.
    Mr. Burton. Well, whoever it was said to her, Mrs. Block, 
we'll settle with you as long as this isn't published. That's 
correct, right?
    Mr. Euler. I think--yes.
    Mr. Burton. I think if you talk to the average citizen in 
this country who was dying and who had to go through this for a 
long period of time, who was suffering from lupus, who was very 
depressed and they said, I'll tell you what we'll do, we'll 
settle this thing as long as you don't publish it, I think most 
people would think that was unseemly by the Federal Government.
    Mr. Harris. I'd like to comment on that, if I could.
    Mr. Burton. Let me just tell you one thing. I'm going to 
ask for a GAO audit. I want you to know this, Mr. Harris, and 
we are going to have all of these cases reviewed. And if the 
GAO can't do it, we're going to have to spot check these, as 
well as the cases of these individuals. So all of this is going 
to be scrutinized by the GAO. I want you to know that. We're 
going to be looking over your shoulder on every case that's 
been decided and every one that's coming up. And you can use 
all the legal technicalities you want to on why you do this and 
why you do that and why you don't want to have things 
published, but I want you to know this is not going to end. 
It's not going to end, and you're going to have Democrats and 
Republicans, whoever is in charge of the Congress, doing this.
    And I just don't understand, you talk about compassion, let 
me just say a couple words here. The Vaccine Compensation 
Program would--and I was in Congress, and I voted for it to 
help the pharmaceutical companies who are afraid of lawsuits, 
as well as making sure that people who had this kind of a 
problem could get a just compensation without going through 
tons and tons of litigation and years of heartache. So I voted 
for it. I was here. But the Vaccine Compensation Program was 
intended by us in Congress to be a remedial compensation 
program, not litigation, as you continue to talk about. We 
didn't intend there to be miles and miles and miles of legal 
wrongdoing going on and for lawyers at the Justice Department 
to be second-guessing and third-guessing a Special Master who 
made a decision.
    In the Barton case, the Special Master who looked at all of 
the information, the medical information, who studied this case 
said there should be compensation. Then they looked at it 
again, because there was some concern with the Justice 
Department. Again the Special Master said, a lawyer, a judge in 
this case, should be compensated. But you went to some other 
expert and said, oh, no, it shouldn't be compensated, and you 
said but we will settle it as long as you don't publish it. 
That just isn't right.
    Mr. Harris. Mr. Chairman, again, I----
    Mr. Burton. Am I misstating what happened?
    Mr. Harris. Well, I'd like to state it in my own words, if 
I could.
    Mr. Burton. Sure.
    Mr. Harris. But I want to say before I do that, I certainly 
appreciate the frustration and the action that you feel, and 
clearly that I understand the frustration and the angst of the 
families and the program participants feel. That is what makes 
our job at the Justice Department a difficult one, because on 
the one hand we are required to implement the mandates of the 
statute.
    As Mr. Cummings said earlier, there is a requirement in the 
statute that these claims be based on credible medical 
scientific evidence. The statute also provides the Justice 
Department in appropriate cases the right to appeal cases that 
we feel are erroneously decided. That is in the statute. We're 
within the statute in doing that, but----
    Mr. Burton. I understand. Let me interrupt you for just----
    Mr. Harris. Oh, no. Why we want to cut down on litigation, 
when we do cut down on litigation by doing things that both cut 
down on litigation and don't hurt the program, is so that we 
can continue to pursue the important national goals of having 
kids vaccinated.
    Mr. Burton. Well----
    Mr. Harris. And----
    Mr. Burton [continuing]. I understand. I understand.
    Mr. Harris. I think that's important.
    Mr. Burton. But we're talking about a specific case here. 
We'll get to the other cases as time goes by and maybe later 
today.
    In the Barton case, you had a judge, a Special Master, who 
has legal standing, who was assigned to review the case, all 
the medical records and everything was looked at. And after a 
great deal of time and study, it was decided to pay the claim. 
There was a concern at the Justice Department about differences 
of opinion, and so they asked it to be rereviewed. It was 
rereviewed, and so then there was a question about, well, we 
don't agree with that, because you are evidently talking to 
some other medical experts, quote-unquote. Obviously the 
Special Master had talked to special experts, not once but 
twice, to make these decisions, and you decided that you would 
appeal the case, even though this had been dragged on ad 
infinitum.
    If that isn't an adversarial type operation, which was 
never the intent of Congress, I don't know what it is. How many 
hoops does a parent like that have to jump through? I just 
don't understand it. That was not the intent. Now, the 
legislation had to be written in legalese. We had to set up 
certain things that had to be done, but we did--it's hard to 
legislate compassion, and if you get lawyers over there who are 
looking strictly at getting in front of a judge or a jury or 
whoever it happens to be to pound their views out, it doesn't 
serve the purpose of what we were trying to accomplish in 
helping both the pharmaceutical companies and the patients and 
their families.
    Mr. Harris. I understand, Mr. Chairman. I think, I really 
do believe that if our attorneys approach these cases in an 
incompassionate way, that they would have appealed this case. 
The fact that they did not appeal this case on one hand and 
preserved the integrity of the program, as we see it, on the 
other hand is I think a testament to the way that we try to 
approach these cases and the difficult balancing situation that 
we have to apply in each case.
    Now, we have had on occasion where appeals have gone 
forward at the petitioner's request, and the result not be what 
the petitioners expected on appeal. And we do not take these 
kinds of appeals frequently. This kind of issue in the 
published versus unpublished decision that we were talking 
about occurs about twice a year max, and right now about 200-
plus cases that we actually resolve each year.
    So it is not something that happens over and over again, 
but on occasion we do differ with the Special Master, and the 
statute provides us the right in those cases to have a 
different person take a look at the case, and of course there 
is where the tension comes in. If we decide that we want a 
different person, the Court of Federal Claims, to take a look 
at the case in this instance, as you heard from Mr. Shoemaker, 
that would probably result in dragging the case out another 3 
years and on the other hand, saying, OK, while we don't agree 
with the Special Master on this decision, we'll compensate the 
victims at this point, as long as we can reach an agreement 
that this decision that we view as erroneous is not published 
and later cited as a legal precedent.
    Mr. Burton. Mr. Gilman, do you have some comments?
    Mr. Gilman. Thank you, Mr. Chairman. I still don't 
understand the rationale for an unpublished decision. I don't 
know of any other court system in our country that has 
unpublished decisions. Our case law is based on precedents, and 
you suddenly are removing that opportunity for the law 
profession to examine prior decisions, and it seems to me that 
you're arbitrarily adopting that kind of a procedure. And I 
have never heard of this in any other agency. Is there any 
other agency that follows unpublished decisions? And if that be 
the case, we certainly want to find out about it.
    Mr. Harris. Mr. Gilman, there are courts throughout the 
land that do have unpublished decisions, and the effect is the 
same, which means that attorneys operating in that jurisdiction 
cannot rely on the unpublished decisions as precedence when 
they are practicing in other cases.
    Mr. Gilman. Well, refer us to at least another agency, a 
Federal agency that has unpublished decisions.
    Mr. Harris. Frankly, I don't study other Federal agencies, 
but this is according to----
    Mr. Gilman. This is the first agency that I've heard that 
has unpublished decisions.
    Mr. Harris. Yes, sir. I think it's important to note again 
that the fact that there are unpublished opinions and published 
opinions is an issue that is decided by the courts. I believe 
that this is a rule of the courts, and I understand that courts 
are today looking at this issue of published versus unpublished 
opinions and may soon offer some comment on whether this 
practice that you're concerned about ought to continue in the 
future.
    Mr. Gilman. And the court has not approved your unpublished 
decision at this point. Is that right? The courts have not put 
their stamp of approval on unpublished decisions? Is that what 
you're telling us, that the issue is now in contention?
    Mr. Harris. I'm saying that the courts have put their 
impression on published versus unpublished opinions, and in 
fact the ultimate decision in each of these cases is one that 
is made by the Special Master. So it's not the Justice 
Department that decides unilaterally that this case decision is 
not going to be published.
    Mr. Gilman. Now, let me follow this. We heard testimony 
that in settling a case, you told the claimant that you would 
settle the case providing they agreed to the decision being an 
unpublished decision. Didn't that come from your Department?
    Mr. Harris. I think that's mostly correct, except to say 
that this is not a settlement issue. It's an issue of whether 
we're going to appeal, and the issue really is----
    Mr. Gilman. Well, no, I'm not talking about the appeal now. 
I'm talking about your conditionality on the settlement.
    Mr. Harris. It----
    Mr. Gilman. That you would settle a case, providing the 
claimant agreed that this would be an unpublished decision.
    Mr. Harris. Yes, sir.
    Mr. Gilman. That seems to me to be putting a great deal of 
pressure on the claimant, so that the case law in that case 
would not be disclosed to other claimants.
    Mr. Harris. And I would respectfully try to explain again 
that this really is not a settlement issue. It's an issue of 
whether we're going to appeal a decision that has already been 
made. In this case the Special Master made a decision that went 
against us that we did not agree with, we strongly disagreed 
with. And the issue was----
    Mr. Gilman. And because you disagreed with it, you didn't 
want it published. Is that correct?
    Mr. Harris. Correct, because we felt that decision would 
interfere with and adversely affect the program objectives that 
Congress set forth, which is----
    Mr. Gilman. Does that excuse the agency for not publishing 
it because you felt that it was erroneous?
    Mr. Harris. I say again, the agency doesn't publish any 
opinions. It's the courts that decide whether an opinion is 
published or not.
    Mr. Gilman. Right. And if you went to the court for a 
settlement, eventually that would be disclosed that there's 
been a settlement, but the court would disclose that. And yet 
you're refraining from allowing the court to publish your 
decision.
    Mr. Harris. If we went to settlement and we settled a case, 
of course the courts would disclose that, unless the file was 
sealed. The only difference between----
    Mr. Gilman. Unless you requested it not be disclosed, which 
you did in this particular case that we heard earlier today.
    Mr. Harris. What we in effect asked the court was that this 
decision not be permitted to be used as precedential value in 
future cases because we strongly disagree with it, and we 
thought that it would undercut the objectives of the act.
    Mr. Burton. Would the gentleman yield just a minute?
    Mr. Gilman. I'd be pleased to, Mr. Chairman.
    Mr. Burton. As I understand it, you sat down with Mrs. 
Barton and her family, and you said--your Department--here's 
what we'll do. We'll settle this, but you've got to sign the 
document, and the agreement is going to be that you're not 
going to request that it be published. That was given to the 
court, and the court decision then was this is a settlement, 
and it's not going to be published. Right?
    Mr. Harris. The court's decision was that----
    Mr. Burton. But it was signed--it was agreed to and it was 
signed by her before it went to the court for the court to 
ratify it?
    Mr. Harris. By her counsel, correct.
    Mr. Burton. Right. But the point is, it was a suggestion by 
the Justice Department to the court in writing that she had 
signed and agreed to, that it would not be published and that 
she would get a certain amount of money in the settlement?
    Mr. Harris. Correct and----
    Mr. Burton. OK. But the point is this, she didn't want to 
do that, but in order to get the settlement, you hand the pen 
to her and you say, look, if you want the money and you don't 
want the appeal, then what we want you to do is we want you to 
sign this because we're going to give it to the court and it's 
going to be an order of the court saying we're paying this 
money and we're requesting that it not be published and you 
agree to that.
    Mr. Harris. The option that the petitioner had in this case 
was, one, to jointly agree to petition the Special Master, that 
the decision be unpublished, the erroneous decision.
    Mr. Burton. And she signed it and----
    Mr. Harris. It was jointly--that's correct.
    Mr. Burton. It went to the court and it was in the court 
order. It was in the court order then.
    Mr. Harris. They just reissued the first----
    Mr. Burton. But I mean the court agreed to it and that was 
the court order and----
    Mr. Harris. But----
    Mr. Burton. But the point Mr. Gilman and I are both making, 
and I think every Member of Congress would make the same thing, 
every Democrat or Republican, was that she wanted to get this 
thing settled. She was sick, had lupus. Her son had died. This 
had gone on for ad infinitum. The Special Master on two 
occasions said it should be paid. You didn't agree with that, 
and so you said, you sign this agreement and we'll give you the 
money, and the agreement is that you agree that it's not going 
to be published and the court will make the agreement that is 
in law, that the court agrees passes on.
    Mr. Harris. I would only alter what the--your statement by 
saying that it was totally--that we actually approached this in 
a more considerate and compassionate way.
    Mr. Burton. Really?
    Mr. Harris. Yes, and I would like to explain.
    Mr. Burton. How many years transpired between the first 
time the Special Master made a decision and you ended up 
agreeing to the settlement? How long a period was that?
    Mr. Harris. I believe it was--the first--if you would 
repeat that.
    Mr. Burton. The Special Master made a recommendation it 
would be settled. When was that? What date?
    Mr. Euler. That was in February. The final decision was 
issued in June.
    Mr. Burton. So it was about 4 or 5 months?
    Mr. Euler. Right.
    Mr. Burton. And during that time it had been reviewed a 
second time by a Special Master and you went and reached an 
agreement?
    Mr. Harris. Yes, sir.
    Mr. Burton. She was ill during that time, too. She had gone 
through 6 or 7 years of all this hell, and then she was told, 
this is what it is going to be or we're going to continue to 
run this thing on for another year, 2, 3, 4 years or however 
long it takes, and that is compassionate?
    Mr. Harris. Well, I would like to explain, if I could. 
We're aware of Mrs. Barton's condition, and obviously 
sympathetic to what had happened to her son. Congress charged 
us to administer this program and to ensure that compensation 
under this program is based on credible scientific evidence. 
That is the charge that we have from Congress.
    Mr. Burton. Credible scientific evidence. The Special 
Master said twice there was credible scientific evidence.
    Mr. Harris. The same Special Master----
    Mr. Burton. Said twice.
    Mr. Harris [continuing]. Looked at this, and we wanted a 
different level of appeal to--we wanted to take this to the 
Court of Federal Claims. So it did----
    Mr. Burton. Well, who in the Justice Department had this 
medical expertise that thought it should be appealed twice 
after a second opinion by the Special Master? Do you have 
somebody over there that has both a law and medical degree?
    Mr. Harris. No.
    Mr. Burton. Because the Special Master made a decision. You 
wanted to rereview it. The Special Master reviewed it again. 
After looking at all the medical evidence and talking to 
experts, they made that decision. And then some lawyer over 
there said, well, we don't agree with that, so we're going to 
get somebody else in the medical profession to review it. Is 
that correct?
    Mr. Harris. No.
    Mr. Burton. That's not what happened?
    Mr. Harris. No, Mr. Chairman. Actually what happens is when 
there are issues involving very medically complex situations, 
as was the case here, because we don't have--as lawyers don't 
have the medical knowledge to make those kinds of 
determinations, we consult with a panel of doctors that have 
expertise in the area that are nationally renown and have great 
credentials, and they are concerned about the program's 
objectives, too, that nothing be done or decisions not be 
published that would hurt the objectives. That's to say that 
this kind of vaccine causes this kind of injury, because then 
folks might have a different view about taking the children to 
be vaccinated.
    Mr. Burton. Do any of those----
    Mr. Harris. So we get that kind of information and rely on 
that medical expertise. In rare cases, as I said before, 2 out 
of maybe 200 a year, do we take this step.
    Mr. Gilman. Mr. Chairman, if I might reclaim my time, I'm 
not going to be able to return. Mr. Balbier, did you on behalf 
of HHS go to this kind of conditional settlement without 
disclosing the prohibited disclosure of the case determination? 
Did you agree to that?
    Mr. Balbier. Mr. Gilman, my understanding is that a--
whether a decision is published or not----
    Mr. Gilman. No, I'm just asking you not what you consider, 
did you agree in this particular case that this decision would 
not be published? Were you consulted, and did you agree to 
that?
    Mr. Balbier. Yes, sir.
    Mr. Gilman. And was it because you're trying to protect the 
agency? Is that why you agreed to it?
    Mr. Balbier. We believed that the Special Master made a 
mistake in the decision, and this case had not gone to a judge.
    Mr. Gilman. Did you have any other cases of that nature 
where you have made that agreement?
    Mr. Balbier. There have been very few cases----
    Mr. Gilman. And were there other cases where you made such 
an agreement? Can you answer that yes or no?
    Mr. Balbier. To be real honest, I honestly don't remember 
whether a decision would be published or not coming up as a 
major issue in terms of whether we would settle a case or not. 
This case, as I understand it, was not really settled in the 
way that we normally think of settlements. This was decided 
by----
    Mr. Gilman. Will you provide to our committee the number of 
cases where you withheld the decisions for publication? Can you 
provide us with that following this hearing?
    Mr. Harris. I don't think we can provide that information 
because all of these decisions are reached typically in 
informal settings, where there is no reporter, it's off the 
record. And because it's off the record, it's not reflected in 
any----
    Mr. Gilman. Well, I'm sure your Department has some record 
of these cases, and I'd like to ask you, with the chairman's 
indulgence, that you provide our committee with the number of 
cases where the decisions were not reported. Can you do that?
    Mr. Harris. I would be happy to.
    Mr. Gilman. And I have one other question.
    Mr. Burton. We have about 7 minutes on the clock.
    Mr. Gilman. Yes. One other question. When you see that 
there's a bad lot of vaccines based on the cases coming before 
you, what do you do with regard to that? Do you report that to 
some agency? Do you try to do something to correct the bad lot? 
What does your Department do once you find there's a bad lot 
claimed?
    Mr. Harris. We handle the legal issues, and maybe HHS is in 
a better position to answer questions about that.
    Mr. Gilman. Mr. Balbier, what do you do when there's a bad 
lot?
    Mr. Balbier. That comes under the jurisdiction of the Food 
and Drug Administration.
    Mr. Gilman. Oh, you mean once you people find there's a bad 
lot, you throw up your hands and say that's another agency?
    Mr. Balbier. No, sir. No, sir.
    Mr. Gilman. Well, what do you do when you find there's a 
bad lot of vaccines?
    Mr. Balbier. We have not found that there is a bad lot of 
vaccines.
    Mr. Gilman. We just heard some testimony today about a bad 
lot, and the case is based on a bad lot. Isn't that correct, 
Mr. Harris?
    Mr. Harris. The first I heard of the issue of there being a 
bad lot of vaccine, clearly this is, to say the least, a very, 
very serious issue, and someone with proper jurisdiction should 
look into whether in fact there are.
    Mr. Burton. Well, we have that jurisdiction, and we're 
issuing a subpoena this afternoon on that. Let me just--I'm 
going to--you're going to have to stay for a little bit because 
we have some more questions for you. I'll be back in about 10 
minutes, but one of the questions I have to ask, Mr. Balbier, 
do you have any stock or do you have any financial interest at 
all in any pharmaceutical companies?
    Mr. Balbier. No, sir.
    Mr. Burton. You have none?
    Mr. Balbier. None.
    Mr. Burton. Have you ever had any?
    Mr. Balbier. No, sir.
    Mr. Burton. Never had any financial interest in any 
pharmaceutical company?
    Mr. Balbier. No.
    Mr. Burton. Do any of the people that you know of who are 
in the decisionmaking process at FDA or HHS own stock or have 
any financial interest of any type in any pharmaceutical 
company?
    Mr. Balbier. I can't answer that question.
    Mr. Burton. Have we subpoenaed all of those records from--
OK. I want to issue a subpoena for all of the financial records 
of the top decisionmakers at HHS, too. OK.
    We'll be back in just a minute. We stand in recess. I'll be 
back in about 10 minutes.
    [Recess.]
    Mr. Burton. I know that you gentlemen have been here a long 
time, so I'm going to try to not belabor this. I would like to 
preface my questions. I just have a series of them for the 
record, and then we'll be finished, but I'd like to say that 
there's a great deal of suspicion, not just from this 
Congressman but from others about the connection between 
pharmaceutical companies and people who are making decisions in 
the various agencies in government, not necessarily the Justice 
Department, but you in the Justice Department are relying upon 
people in the health agencies for some of the decisions that 
you're making. Now, the RotaShield virus was a concern. It 
wasn't something that was really going to be that fatal, but 
they came up with a RotaShield vaccine, and as I said before, 
you probably heard me, the RotaShield vaccine was decided to be 
put into the marketplace by an advisory commission. Now, the 
advisory commission doesn't make the final decision. It's made 
by the FDA. But the FDA has never, ever, that we can find, 
turned their back on a decision made by the advisory 
commission. So in effect, the advisory commission makes the 
decision. The head of the advisory commission that put the 
RotaShield vaccine on the market, the head of that advisory 
commission, was a man who owns stock, a lot of stock in the 
company that made the RotaShield virus--vaccine, was in the 
process of doing that. There was a concern raised about it and 
not enough testing but they put it in the marketplace anyway. 
And the way they did it--I won't go into all of the details--in 
a year some children had died. Many others had been adversely 
impacted and they pulled it off of the market.
    Now, the reason I bring that subject up is I hope you, Mr. 
Harris and Mr. Euler, at the Justice Department, will take a 
hard look at the connection between people at the health 
agencies who are involved in the decisionmaking process, who 
may have other reasons for taking positions that they do, 
especially in view of the Victims Compensation Program. If 
you've got people out there who are having their kids dying or 
become autistic, or whatever the case may be, and you find that 
there's lots of vaccines, that according to--who was it? Ms. 
Dyer--that she found out that was a bad lot, and yet that 
cannot be made public. Why can't it be made public? Why was 200 
or 300 people adversely impacted by that, other than maybe they 
didn't want that public, because the pharmaceutical company 
would have a black eye and it might hurt sales and it might 
hurt business? It might keep people from making a lot of money.
    Now, I'm a free enterprise advocate, big time, you know, 
but not where health is concerned. If somebody is covering up 
or hiding information that may adversely impact the people of 
this country, then we've got to do something about it. Now, the 
Victims Compensation Fund that we established was supposed to 
be a way for people to get compensation from vaccine injuries 
without a lot of litigation, without any litigation really, but 
nevertheless we've gotten into that.
    But the other end of it was that we were protecting 
pharmaceutical companies from liability suits. They said that 
they couldn't produce a lot of vaccines in bulk, because they 
had so many suits and they wanted to be protected. So we agreed 
in Congress that we would provide a mechanism for them to put 
money into a fund so there wouldn't be a lot of litigation, 
we'd protect them and we'd be able to take care of the public 
at the same time. It sounded like a winner for everybody. It 
has helped a lot of people, but it hasn't been perfect, and I 
still am suspicious and we have found--I have subpoenaed 
financial documents from people in the FDA, and we have found 
that there are conflicts of interest, that people have owned 
stock in pharmaceutical companies who were in decisionmaking 
positions. And that is something that I hope you'll look at, 
because it's your responsibility at the Justice Department to 
make sure these things are handled adequately and right, and 
we're going to continue to do that, but I think you really--we 
may disagree, but I think you're sincere that you want to do 
the right thing to help make sure people are compensated 
properly.
    But if this gentlelady from Tennessee found that there was 
a bad lot and 200, 300 people were adversely affected by this 
vaccine, she did not get compensation. She cannot get 
information, except through the Freedom of Information Act, and 
there is a whole bunch of other information that is being 
withheld. It needs to be looked at, because if there was a bad 
lot and all those people were injured, they ought to be 
compensated. You see what I'm saying?
    Mr. Harris. Yes. Yes, Mr. Chairman.
    Mr. Burton. I hope you'll----
    Mr. Harris. And I am very sympathetic to your concern here, 
and I will take your statements back to my boss, who I'm sure 
will handle it appropriately.
    Mr. Burton. What I'd like to do is have Beth here and I, 
when we get this information, share it with you so that you can 
be a colleague, if you will, in trying to get to the bottom of 
this and make sure that everybody is being treated fairly. That 
would really help.
    Now, Mr. Euler and Mr. Harris, let me ask you real quickly 
a few questions. Then I'll let you go have dinner and me, too. 
You've heard Lori Barton's testimony. My staff discussed this 
case with you last week. Have you had a chance to review it?
    Mr. Euler. Yes.
    Mr. Burton. You have had a chance to review it.
    I'd like for each of you to tell me if you think the 
Justice Department handed that case appropriately. Do you think 
they did? And you know we've talked about this--or talked about 
this sometime now.
    Mr. Euler. Yes, Mr. Chairman. I appreciate it. The case was 
very, very difficult medically. As I think has been pointed 
out, there was an alternative condition. Mr. Harris was able to 
pronounce the name of that condition, which essentially means a 
loss of white matter from the brain. So that was the central 
thing that made the case very difficult.
    In the words of the Special Master, there were agonizing 
delays which weren't particularly anybody's fault. The 
petitioner had a difficult time getting records. The petitioner 
filed several motions for summary judgment, for example, and 
then in the middle of the case where we had this very difficult 
condition, which our medical evidence indicated was the real 
cause of the condition and it was not vaccine related, the 
child died. And as the Special Master pointed out, that created 
a new kind of case. It had to be reviewed from that sort of 
standard, and we moved it along as quickly as we could.
    Now, I'm concerned about what was said concerning the 
cross-examination that occurred at the hearing. We do not 
condone confrontational cross-examination. Mr. Chairman, I hear 
you on that. This program has to have a human face, and I'd 
like to kind of, if I could, tell you what I try to do about 
that, if you have just a moment.
    Mr. Burton. Sure. No, no.
    Mr. Euler. I know we're all busy. We start with the 
interview process. When we interview somebody coming into the 
program, we say this is different. Not every lawyer can handle 
this. This is a case that involves injured people who believe 
more seriously that they have an injury. You may have to ask 
some hard questions, but you will treat people with compassion, 
and you will treat them with courtesy and you will treat them 
with respect and empathy, because they are in fact people that 
have had a tragedy, and then the question is, can you do that, 
can you handle that?
    So that is where it started. We repeat that all the time in 
the staff meetings. When we showed the staff a tape of your 
hearing last time--that was required for all of them to sit 
down and see the hearing that we had, I think it was in 
November, so that they could see what the issues were, so that 
they could see what the concerns were. And then if something is 
brought to my attention, I look into it.
    Now, the Barton cross-examination was never brought to my 
attention. It was not reflected in the decisions. The Special 
Master never personally brought it to my attention, nor did 
petitioner's counsel. If they had, I would have looked into it 
at the time and I would have taken--and I say that because 
that's not what we're about.
    Mr. Burton. OK.
    Mr. Euler. And that's what I tell my people.
    Mr. Burton. Well, the Special Master, though, to my 
knowledge never relented on the opinion that he had that this 
should have been a paid case?
    Mr. Euler. That's correct. That's correct.
    Mr. Burton. So--and the one thing that was--I'm sure you 
relied at least in part on recommendations from the health 
agency as to whether or not this should be appealed?
    Mr. Euler. Yes, sir.
    Mr. Burton. Well, in the future when you look at those 
cases, I hope you'll be a little--I don't mean to be 
suspicious, but I hope you'll be a little interested in whether 
or not there is an interest to an outside entity that may be 
involved. Now, if you find cases that might set a precedent 
where a vaccine injury might cause repercussions out there for 
an investment, a company that has an investment like a 
pharmaceutical company, you might look at that at least with a 
jaundiced eye before you make a decision, because after all of 
the hearings we've had and all of the research that we've done, 
Beth and others, and I am convinced that in some cases, not in 
all cases, but in some cases there is outside influence, and 
it's very unfortunate because it does have an adverse impact on 
a lot of people.
    Now, you heard me read the remarks of the Special Master in 
that case, the Barton case, and you heard Lori Barton state 
that she felt she was being--well, we've already answered that. 
In fact, you've already answered that just now. Mr. Harris, you 
weren't around back in 1993. You're much too young for that. 
And Mr. Euler, were you supervising this office at that time?
    Mr. Euler. I was.
    Mr. Burton. Oh, you were?
    Mr. Euler. Yes, sir.
    Mr. Burton. And this matter was brought to your attention?
    Mr. Euler. It was not until now.
    Mr. Burton. OK. Well, that answers that question.
    Do either of you think that it's appropriate that the 4 
years expired between one hearing and the next? That is an 
awful long time. Why did----
    Mr. Harris. That is a long time, Mr. Chairman. I would like 
to----
    Mr. Burton. The child may be--you know, the next condition, 
succumb to it, I mean----
    Mr. Harris. Right. I agree with and concur with everything 
that Mr. Euler just stated, but as the representative of the 
administration, I want to assure you that this administration 
is absolutely committed to making sure that your concerns about 
a compassionate program are addressed. And I wasn't here when 
these awful things happened to Mrs. Barton as she alleged 
during the course of her case proceedings, and the Department 
and the administration regrets that any program participant is 
ever treated in that way. And we will be certain to take 
measures in the future to ensure that this does not happen, 
because this is not something that we will tolerate in this 
administration.
    Mr. Burton. When we subpoena this information--and I hope 
you might do likewise, but if you don't, I will provide this to 
you once we get the documentation. But when we subpoena 
information regarding the Tennessee case that we heard here 
today, if we can corroborate what has been said, I'd like for 
you to have that so you can look at that and find out why--if 
that was a bad lot and there were all those adverse events, why 
those cases weren't looked at in a little different light, 
because it wasn't just this case. But if there were several 
hundred, like she alleged--I think you said there were 200 or 
300. How many?
    Mrs. Dyer. 246.
    Mr. Burton. 246 cases and it was from this same lot, the 
same lot number. That's something that should really be looked 
into, and we're going to subpoena that. And if you could do 
likewise or if you want to wait and we'll give it to you, we'd 
like for you to take a look at that as well.
    Now, this is a tough question. Do you have any regrets 
about the Barton case, them having to choose between the 
opinion unpublished or facing that appeal?
    Mr. Harris. Well, I'm glad you raised that issue. The 
regret that I have is that it caused additional trauma to a 
family that was already traumatized very, very personally in an 
unfortunate event. That I'm very sympathetic with.
    I would like to clarify this distinction between an 
unpublished decision versus a public decision. An unpublished 
decision, first of all, there are courts throughout the land 
that frequently issue unpublished decisions, district courts in 
Virginia are courts not of record. There are no opinions on 
that. Second, the Special Masters under this program issue 
unpublished decisions in most of the cases that they decide on.
    Mr. Burton. Well, then why did that question even arise? 
Why would that even come up? If you thought it might not be 
published, why would you even say this is conditional upon this 
being an unpublished case?
    Mr. Harris. Because the Special Master had decided to 
publish.
    Mr. Burton. OK. So the Special Master thought it was 
relevant for future cases, otherwise he wouldn't have requested 
it be published?
    Mr. Harris. Correct.
    Mr. Burton. And so you've got to look at this. He had two 
reviews of it. He thought it should be published, because he 
wanted it to be a precedent?
    Mr. Harris. Right.
    Mr. Burton. And you guys didn't agree, and you were 
concerned about that, and so you made the decision. So once 
again----
    Mr. Harris. I think if we look at this fairly from both 
sides and go back to the Dyer case or any case where a Special 
Master makes a decision that is adverse to the petitioners, 
certainly we wouldn't want to foreclose their opportunity to 
appeal, and I don't think it's fair as a matter of justice to 
foreclose the opportunity for us to appeal when we're not 
satisfied with the Special Master decision.
    Mr. Burton. See, we have a difference of opinion, because 
this was supposed to be a program with a heart, where people 
who got a just settlement wouldn't have any concern, but people 
who didn't have a just settlement would have the right to 
appeal. That didn't necessarily mean in our opinion, and I 
don't think any Congressman, at least the ones I talked to, 
felt like the Justice Department ought to be fighting what was 
considered a just decision. So you're saying, well, it ought to 
be fair on both sides. I think in most cases that go before a 
court you're right, but in this particular case we're talking 
about people who need compassion, and we tried to protect the 
pharmaceutical companies as well as to show compassion. So the 
way we thought the compassion should be shown--and I remember 
all of these issues vividly when the legislation came up--was 
that they would get a just settlement. If there wasn't a just 
settlement, there would be an appeal process. But I don't think 
we envisioned that the Justice Department would be fighting 
people wanting to--you know, when a decision had been reached.
    Mr. Harris. I understand that, Mr. Chairman, I really do, 
and I'm sure that our attorneys understand that as well, which 
is reflected in the extreme infrequency with which we petition 
the courts to make a decision that they've already decided 
should be made published to be unpublished. The effect is that 
an unpublished opinion does not have precedential value. It is 
available to the public.
    Mr. Burton. No. I understand.
    Mr. Harris. So if someone wanted to find out what happened 
in this case----
    Mr. Burton. No. I understand.
    Mr. Harris [continuing]. They could walk into the court----
    Mr. Burton. No. I understand. But a Special Master who was 
a judge in this case and had reviewed the case twice wanted it 
to be a precedent setting case, but you didn't. And where did 
you get the information that you used in saying that you might 
appeal it and that you didn't want it published? You got that 
information from the health agencies?
    Mr. Harris. Not just the health agencies. In part, that is 
true. We get that from the health agencies, but in all 
fairness, there were anywhere from three to six cases, PVL 
cases prior to this one, where Special Masters had decided that 
this was not a condition----
    Mr. Burton. Caused by vaccination?
    Mr. Harris. Correct. And so we have to consider that as 
well.
    Mr. Burton. No. I understand, but I hope you'll at least in 
the future, when you get these--if there's a case that's 
decided, let's say by a Special Master, and it's reviewed by a 
Special Master and then somebody at the health agency says, 
well, you know, we don't agree with that and you ought to take 
another look, and they try to convince you that it should be 
appealed, look at that real thoroughly because there may be 
other reasons why.
    And Mr. Balbier, I have just two questions for you. Did you 
have a chance to review the Barton case?
    Mr. Balbier. No, I did not.
    Mr. Burton. Who in your agency made the recommendation that 
the case be appealed?
    Mr. Balbier. We----
    Mr. Burton. Didn't you make a recommendation or discuss 
this with the Justice Department people?
    Mr. Balbier. At the time the decision was made by the 
court, is that----
    Mr. Burton. No, no, before the court made the decision, 
didn't your agency recommend to the people at the Justice 
Department that were talking about an appeal, didn't you make 
some kind of a recommendation or give them some information 
about this?
    Mr. Balbier. Yes, sir. The way the process works is that's 
the very beginning of the process, is that one of our medical 
officers that work with the program reviews the case.
    Mr. Burton. After the Special Master made a decision?
    Mr. Balbier. Actually before. What we do is we provide 
recommendations to the Special Master----
    Mr. Burton. OK.
    Mr. Balbier [continuing]. For decision.
    Mr. Burton. Let's talk about this case. The Special Master, 
you gave him information, he reviewed it. He said it should be 
settled. He reviewed it again, because the Justice Department 
people said it should be reviewed. Evidently you had not 
convinced him. And he said, yes, it should still be paid.
    Then you talked to the--or somebody from your agency talked 
to the Justice Department and said this should be appealed. Is 
that correct?
    Mr. Balbier. I do not remember the discussions on that 
particular case. I----
    Mr. Burton. Can you find out? Can you run the traps on that 
and get the information for us?
    Mr. Balbier. We can look at our records and go back and----
    Mr. Burton. Yeah. I'd like to find out what exactly 
transpired.
    Mr. Balbier. I can tell you--yes.
    Mr. Burton. And I understand what you're saying, at the 
beginning you give a recommendation based upon the information 
you have to the Special Master, but in this case he made a 
decision, maybe you didn't agree with it. The second time he 
reviewed it he made the decision you may not agree with. I want 
to find out if after that there was a recommendation made that 
there be an appeal directly to the Justice Department.
    Mr. Harris. I think I can state for certain that HHS as our 
client, that the Justice Department work closely with HHS in 
the decision that you're concerned about, which is whether to 
stop the litigation, to forego the trauma and the pain and just 
to cut this short and have an unpublished decision. That was 
jointly discussed in consultation between Justice Department 
officials and HHS. And it's my understanding that officials at 
HHS rely heavily on medical experts that are familiar, in this 
case with PVL, when they make--and I know you're concerned--
when they make this kind of a decision. So if the question was 
was there a consultation, the answer is yes.
    Mr. Burton. Medical experts, many of whom serve on advisory 
committees, who have financial interest in the pharmaceutical 
company, do they have a tainted view when they make those 
recommendations? Those are things I hope you'll look at in the 
future.
    We normally don't do this, but Mrs. Barton, did you have 
something?
    Mrs. Barton. I just wanted to say that the second hearing 
on August 7, 1997 was the medical expert hearing, and during 
that hearing PVL, periventricular leukomalacia, was discussed 
between both our medical expert and the respondent's medical 
expert at that hearing during that entire day with the Special 
Master there. So that was what the entire day was about, was 
about the PVL.
    Mr. Burton. OK. This was prior to the second decision made 
by the Special Master?
    Mrs. Barton. Yes. This was----
    Mr. Burton. And he still----
    Mrs. Barton. He was still alive, he was still alive at this 
point. This was the second hearing.
    Mr. Burton. OK. All right. Let me ask one more question. 
Even acknowledging the fact, Mr. Balbier, that there was some 
complicated issues involved, do you think this case was handled 
appropriately from the standpoint of the health agencies?
    Mr. Balbier. Well, again, Mr. Burton, we too would like to 
see the process made more expeditious, as much as it can be. 
That's exactly why we've proposed legislation to try to do 
that. So our goal has always been to try to get cases processed 
through the system just as quickly as we can. This case did 
take a long time. I wish it hadn't.
    Mr. Burton. Well, hopefully we'll----
    Mr. Balbier. We'd like to get them all handled much faster. 
It's a common goal that we all have.
    Mr. Harris. Mr. Chairman----
    Mr. Burton. Let me--I'm sorry, go ahead.
    Mr. Harris. If I could take a minute to clarify a couple of 
things on the record, I would appreciate it.
    Mr. Burton. Sure.
    Mr. Harris. There has been much discussion about published 
and unpublished decisions in the context of a settlement, and I 
tried earlier to make clear that what we're talking about here 
is not a settlement. It's a decision on whether to appeal. And 
I think this is important, because in fact we do settle many 
cases that are processed through our program, and in none of 
those settlement cases is there any provision that the 
stipulations in the settlement provision should not be made 
public. We never do that, and I just wanted to be absolutely 
clear about that as a----
    Mr. Burton. But in this case----
    Mr. Harris [continuing]. A practical matter.
    Mr. Burton [continuing]. The Special Master wanted it 
published but it was a condition of the settlement, according 
to Mrs. Barton. She had to sign that document saying that she 
would not request it be published in order for her to get that 
settlement.
    Mr. Euler. That there would not have been a document.
    Mr. Burton. That there would not be an appeal.
    Mr. Euler. There would have just been an informal 
arrangement between counsel, and we assumed counsel talked to 
her counsel----
    Mr. Burton. That was not in any document given to the 
court?
    Mr. Euler. That's correct.
    Mr. Harris. These are informal. Our attorneys sit down with 
the petitioner's attorney off the record in an informal 
setting. There's no arm-twisting.
    Mr. Burton. So there was nothing given to the judge 
saying--that was not requested by the Special----
    Mr. Harris. A petition to the Special Master is a joint 
petition that both parties file with the Special Master.
    Mr. Burton. And did that document say that there would not 
be a request for publishing it?
    Mr. Euler. Now, even that would have been by an informal 
status conference. In other words, the parties would have got 
on the telephone with the court and said we both agree that the 
opinion should not be published. I don't think there's----
    Mr. Harris. There's no documentation where we----
    Mr. Euler. So I just want to be----
    Mr. Burton. There's no paper trail to that, but the fact is 
the Special Master would request that it be published had it 
not been for this agreement?
    Mr. Euler. We do appreciate your concern. As I mentioned to 
your staff, this is an issue we hadn't been aware of before, 
and we appreciate the concern.
    Mr. Burton. In looking at the level of research evidence on 
a possible causal connection between an injury and a vaccine, 
does HHS consider whether or not research was funded by the 
vaccine manufacturer, Mr. Balbier? When you're looking at the 
level of research evidence on a causal connection between an 
injury and a vaccine, does HHS consider whether or not the 
research was funded entirely or in part by the vaccine 
manufacturer?
    Mr. Balbier. Not to my knowledge. We don't look at actually 
how the research was funded. Most of the research is actually 
funded by the Federal Government, including----
    Mr. Burton. But----
    Mr. Balbier. Even CDC.
    Mr. Burton. But the vaccine manufacturers have funded a lot 
of this research?
    Mr. Balbier. Indeed they do.
    Mr. Burton. And they work with some of the people over 
there at HHS quite frequently in trying to solve problems, and 
they would have a fairly good relationship many times?
    Mr. Balbier. And research is peer reviewed and it's subject 
to the requirements of the journal that it's published in, and 
they're the ones that have responsibility for deciding what 
gets published, whether they're--and that sort of thing. We 
don't get involved in those decisions certainly.
    Mr. Burton. Is it true that the Finnish epidemiological 
study that the HHS uses to discount laboratory research by Dr. 
Wakefield that there's no connection between the MMR vaccine 
and autism was funded by the Merck Laboratories, or do you know 
the answer to that?
    Mr. Balbier. Well, I certainly have no special expertise in 
that area, but I can say that what I understand is that it 
would be absolutely impossible to prove from a scientific 
standpoint any sort of a negative assertion; so that's not 
something that would even be possible in science to prove that 
any vaccine cannot and absolutely cannot cause any particular 
injury.
    Mr. Burton. Well, but I think that's not my question. Maybe 
I didn't state it. I said is it not true that the Finnish 
epidemiological study that HHS uses to discount laboratory 
research by Dr. Wakefield that there is no connection between 
the MMR vaccine and autism was funded by Merck? Do you guys 
know if it was funded by Merck?
    Mr. Balbier. I'm not aware, sir. I don't know.
    Mr. Burton. Well, I wish you would look into that if you 
would and give us an answer because according to the 
information we have is that it was funded by Merck through this 
Finnish epidemiological organization and that HHS is using that 
study as a reason to discount a lot of the assertions made by 
Dr. Wakefield and if it was funded by a pharmaceutical company 
that has a financial interest in discounting what he did, it's 
something that you guys ought to take a look at, and we'd like 
to know about because that's the information we have.
    Let me just end up, I don't know if the gentlemen from HHS 
and the Justice Department want to apologize to you, Mrs. 
Barton, for what you had to go through but we certainly will 
and I'll leave it up to them. And to you, Mrs. Dyer, please 
forgive me for forgetting your name, but we will continue to 
pursue the information. We will issue that subpoena and we will 
get the information on that lot, and maybe 1 day there will be 
vindication for you. We don't know, but we'll sure look into 
it. And with that, thank you very much.
    I'm sure that you, Mr. Balbier, Mr. Harris, and Mr. Euler 
will all get to know each other a lot better. Maybe I'll serve 
cookies and coffee the next time you come up, but we'll see you 
soon. Thank you very much. We stand adjourned.
    [Whereupon, at 6:15 p.m., the committee was adjourned.]
    [Additional information submitted for the hearing record 
follows:]
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