[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
COMPENSATING VACCINE INJURIES: ARE REFORMS NEEDED?
=======================================================================
HEARING
before the
SUBCOMMITTEE ON CRIMINAL JUSTICE,
DRUG POLICY, AND HUMAN RESOURCES
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 28, 1999
__________
Serial No. 106-136
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
U.S. GOVERNMENT PRINTING OFFICE
66-079 CC WASHINGTON : 2000
COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio
Carolina ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia DANNY K. DAVIS, Illinois
DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
LEE TERRY, Nebraska THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California ------
PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont
HELEN CHENOWETH, Idaho (Independent)
DAVID VITTER, Louisiana
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
David A. Kass, Deputy Counsel and Parliamentarian
Carla J. Martin, Chief Clerk
Phil Schiliro, Minority Staff Director
------
Subcommittee on Criminal Justice, Drug Policy, and Human Resources
JOHN L. MICA, Florida, Chairman
BOB BARR, Georgia PATSY T. MINK, Hawaii
BENJAMIN A. GILMAN, New York EDOLPHUS TOWNS, New York
CHRISTOPHER SHAYS, Connecticut ELIJAH E. CUMMINGS, Maryland
ILEANA ROS-LEHTINEN, Florida DENNIS J. KUCINICH, Ohio
MARK E. SOUDER, Indiana ROD R. BLAGOJEVICH, Illinois
STEVEN C. LaTOURETTE, Ohio JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
DOUG OSE, California JANICE D. SCHAKOWSKY, Illinois
DAVID VITTER, Louisiana
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
Sharon Pinkerton, Staff Director and Chief Counsel
Mason Alinger, Professional Staff Member
Lisa Wandler, Clerk
Cherri Branson, Minority Counsel
C O N T E N T S
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Page
Hearing held on September 28, 1999............................... 1
Statement of:
Balbier, Thomas E., Jr., Director, National Vaccine Injury
Compensation Program, Department of Health and Human
Services; John L. Euler, Deputy Director, Torts Branch,
Civil Division, Department of Justice...................... 102
Clements, Michele, petitioner and mother of injured child,
Milwaukee, WI; Linda Mulhauser, petitioner and mother of
injured child, New York, NY; and John Salamone, president,
Informed Parents Against VAPP.............................. 17
Kinsbourne, Marcel, medical expert, Tufts University; Arnold
Gale, medical expert, Stanford University; and Cliff
Shoemaker, attorney, Shoemaker & Horn...................... 51
Letters, statements, et cetera, submitted for the record by:
Balbier, Thomas E., Jr., Director, National Vaccine Injury
Compensation Program, Department of Health and Human
Services:
Information concerning timelines......................... 195
Prepared statement of.................................... 105
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, information concerning backgrounds.......... 131, 147
Clements, Michele, petitioner and mother of injured child,
Milwaukee, WI, prepared statement of....................... 22
Euler, John L., Deputy Director, Torts Branch, Civil
Division, Department of Justice, prepared statement of..... 115
Gale, Arnold, medical expert, Stanford University, prepared
statement of............................................... 65
Kinsbourne, Marcel, medical expert, Tufts University:
Information concerning a final argument by Justice of
Department............................................. 53
Prepared statement of.................................... 58
Mica, Hon. John L., a Representative in Congress from the
State of Florida, prepared statement of.................... 6
Mink, Hon. Patsy T., a Representative in Congress from the
State of Hawaii, prepared statement of..................... 15
Mulhauser, Linda, petitioner and mother of injured child, New
York, NY, prepared statement of............................ 31
Salamone, John, president, Informed Parents Against VAPP,
prepared statement of...................................... 37
Shoemaker, Cliff, attorney, Shoemaker & Horn, prepared
statement of............................................... 75
COMPENSATING VACCINE INJURIES: ARE REFORMS NEEDED?
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TUESDAY, SEPTEMBER 28, 1999
House of Representatives,
Subcommittee on Criminal Justice, Drug Policy, and
Human Resources,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in
room 2154, Rayburn House Office Building, Hon. John L. Mica
(chairman of the subcommittee) presiding.
Present: Representatives Mica, Barr, Mink, Cummings,
Kucinich, and Tierney.
Also present: Representatives Burton, Weldon, and Waxman.
Staff present: Sharon Pinkerton, staff director, chief
counsel; Steve Dillingham, special counsel; Mason Alinger,
professional staff member; Lisa Wandler, clerk; Cherri Branson,
minority counsel; Ellen Rayner, minority chief clerk; and Jean
Gosa, minority staff assistant.
Mr. Mica. Good morning. I would like to call this meeting
of the Subcommittee on Criminal Justice, Drug Policy, and Human
Resources to order.
This morning's hearing is entitled, Compensating Vaccine
Injuries: Are Reforms Needed? I would like to start with an
opening statement, and then we will yield to other Members for
the same purpose.
Today, our subcommittee will examine a program that is
responsible for one of our Government's most sensitive and
difficult responsibilities; the duty to compensate fairly,
adequately, and efficiently those individuals who are injured
or die as a consequence of our universal vaccination policy.
This policy is designed to protect us. Without a national
vaccine policy, many illnesses, including measles, polio,
diptheria, tetanus, and typhus, would endanger all of us
especially our children. Research into hundreds of new
vaccines, which range from lowering cholesterol to curing AIDS,
is proceeding at a rapid pace. Our need for new vaccines is an
absolute certainty.
This subcommittee recently held a hearing on the
international AIDS epidemic and related drug treatments and
prevention responses. We learned that vaccine development
represents the best long-term solution for preventing millions
of AIDS-related deaths. I can assure you that people across the
globe are anxiously awaiting an effective vaccine for that
deadly illness.
I commend the many researchers and pharmaceutical companies
for vaccine successes to date, and I wish them God speed in
developing new, safer, and more effective vaccines for the
future. I also commend those who help to administer vaccines.
They have strong support in Congress for accomplishing these
critical missions.
Earlier this year, our subcommittee examined adverse
reactions that have been linked to the hepatitis B vaccine.
Last month, our full committee examined anthrax vaccines and
vaccination practices. Today, we will focus on the workings of
the HHS Vaccine Injury Compensation Program that was designed
to compensate those individuals who are injured from certain
vaccines that we routinely administer to our children.
Despite the life-saving benefits of our national vaccine
practices, we must not forget the cost of these benefits,
particularly to those individuals and families who regrettably
experience tragic adverse reactions. In simple terms, our
vaccines now protect millions. However, in some rare instances
they cause serious harm, even death, to others.
Today, we will examine how we compensate those who are
harmed and consider how we might make the system we have
established for this purpose, again, of compensating
individuals, work even better.
The issue of compensating vaccine injuries is not a
partisan issue. In 1984, my brother, Dan Mica, who was a
Democrat Member of Congress, helped work with other Members of
Congress in creating an awareness for the need to compensate
persons injured from vaccines. Also a leading figure in helping
to create compensation for those who received injury was the
ranking member of our full committee, Mr. Waxman. He was a key
author of the vaccine compensation legislation developed in the
eighties.
Our hearing today is devoted to examining the workings of
the National Vaccine Injury Compensation Program administered
by HHS. Is this program, which was established to be a no-fault
compensation program, operating in a quick, easy and fair
manner, as was originally envisioned by Congress? Is the fund
being administered as required under the law, ``with
generosity,'' in keeping with the program's authorization
language?
In answering these questions, we will hear first-hand from
witnesses who have had experience in the program dealing with
injuries particularly to their children. We will also hear from
attorneys who represent the injured and from experts who
provide medical advice at compensation hearings. Finally, we
will discuss program issues with Government witnesses who
administer the program.
Recently, we have received many letters, calls, and visits
from families of children injured after they were administered
vaccines. We also have heard from practicing attorneys, medical
professionals, and associations with strong interests in this
program.
According to many, the current Compensation Program is not
operating fairly or in the way Congress originally intended. I
want to learn more about these concerns and some of the
problems brought to our attention from both sides and what
should be done to correct these problems.
Today, we will hear that our national vaccine practices can
have rare but sometimes brutal consequences for those who
unfortunately and through no fault of their own, experience
severe and sometimes even deadly adverse reactions. We will
also examine the serious problems experienced by some who have
sought compensation, again, under this system that Congress
created.
Today, we will hear more about these concerns and
recommendations for our Compensation Program. Some issues that
I hope will be addressed today and which may require
legislative changes include some of the following: first, is
the Compensation Program too adversarial; are eligibility and
standard of proof requirements too strict; should we use the
compensation fund for other purposes?
To address the first question, why must injured families
assume the role of petitioners and often go through a
cumbersome adversarial and legal process to get final
compensation determination? Legislative history indicates that
Congress intended just the opposite. The process was intended
to be informal and take no longer than 240 days. Many cases now
take years; in some cases, as long as 5, 6, even 9 years to
reach a final determination.
Why is this? Why must families hire specialist attorneys to
process their claims? Why are attorneys declining in some cases
to deal with these cases? Why are attorney fees not being paid
until sometimes years afterwards?
Families of the injured must now search for the few medical
experts who are willing to testify on their behalf. Should
medical witnesses have their professional credibility
challenged by skilled Department of Justice attorneys seeking
to protect the Government coffers? Must some families devote
their life savings, incur huge debt, and experience personal
hardship while litigation drags on for years? These problems
may or may not be typical, but they do raise the issue of
whether reforms and safeguards are needed today.
Other questions I hope we address in this hearing: Should
the Department of Justice be reimbursed by injured families for
costs of unsuccessful litigation in the Federal Circuit Court?
Should the Government favor and facilitate mediation in place
of litigation? Do we, in fact, victimize again families that
have already suffered terrible harm through what has turned
into an adversarial process?
I wish to learn more about this today from the Government,
from the families, from their attorneys, and from the medical
experts who we have assembled as witnesses.
The second concern I would like to address is whether
eligibility and standard of proof requirements are too strict.
Program participants have told our subcommittee that the
vaccine injury table, the key to deciding claims, is
unnecessarily restrictive. In fact, since 1986, HHS has
restricted coverage dramatically through changes to the injury
table. Were the changes always consistent with medical
research, and were they necessary?
I realize that some will argue that the changes reflect
sound science, which we all support. However, that the table
was not designed to reflect only studies with conclusive proof
of likely injury cases, conditions, or time requirements. The
table also reflects compensation policy. I understand that
judges in the Federal Circuit Court have raised the issue in a
pending case as to the constitutionality of giving the HHS
Secretary authority to revise the injury table.
What will DOJ and HHS do if the court rules against HHS and
the revised table? Will the court stop the program? What would
happen to claims that were denied? I think there are many
unanswered questions here, and I hope that we can learn about
some of these problems and solutions from our witnesses.
In summary, I think some very serious programmatic and
legal issues have been raised that need to be resolved. A key
issue is the injury table. Congress designed the original
injury table with sort of a cushion that included injuries
where the science was unclear. Although some research has
occurred since then, much uncertainty remains as to the causes
of many childhood illnesses.
Families and others have expressed skepticism about relying
on a rigid chart that has been significantly tightened by HHS.
Perhaps the criteria and the spirit of the original table
should be preserved. Considering the incompleteness of vaccine
injury research, I can understand their concerns.
Also, the standard of proof requirements may need to be
reexamined. For example, a claimant's burden might be one of
simply demonstrating that the vaccine was related to the
injury. The Department of Justice could be required to show by
clear and convincing evidence that the injury resulted from
something else in order to defeat the claim.
These are types of simple changes that should be explored
to ensure fairness under circumstances where everyone agrees
the science is incomplete and regretfully will remain
incomplete for many years to come. We must all recognize that
the standards of proof that are applied in compensation
determinations are legal in nature and not scientific.
Finally, I realize that the Federal Government has other
benefit programs, such as those for veterans and law
enforcement officials, which provide that the benefit of the
doubt goes to the injured in resolving benefit claims. Why does
this program provide no benefit of the doubt for injured
children?
The third aspect I would like to address is whether we
should be using the compensation fund for other purposes.
Recent proposals call for using the injury compensation fund
for other purposes, including research and administrative
expenses. While hundreds of potential vaccines are being
developed and concerns have been raised about restrictions in
the injury table, it does not seem to me that it is now the
time to reduce the vaccine tax or to raid the trust fund. The
current tax of 75 cents per dose is not exorbitant, and the
cushion in the fund may only be temporary.
Who can accurately predict what new vaccines and groups of
injured persons will need to be covered in the future? I urge
caution before using the trust moneys to fund immediate or less
compelling needs. If the fund continues to grow over time, we
might consider changes.
In terms of vaccine tax reduction, I think we should first
consider redirecting or eliminating that portion of the vaccine
tax, 25 percent, that goes into the general fund. Then we might
consider use of moneys in the trust fund.
Finally, there is the issue of a possible conflict that
exists in having the Compensation Program as part of HHS. HHS
conducts and encourages vaccine research and promotes
vaccination policies and programs. Concerns of possible
conflicts increase when considering the Advisory Commission
that oversees the Compensation Program. Should the commission
use HHS staff? Should HHS override commission recommendations?
I look forward to hearing from our witnesses today on these
and other issues. I extend my sincere thanks to those who have
traveled long distances at great personal sacrifice to be with
us and provide testimony. We sincerely appreciate your
willingness to share your thoughts, your concerns and your
recommendations on these important issues.
[The prepared statement of Hon. John L. Mica follows:]
[GRAPHIC] [TIFF OMITTED] T6079.001
[GRAPHIC] [TIFF OMITTED] T6079.002
[GRAPHIC] [TIFF OMITTED] T6079.003
Mr. Mica. Now I am pleased to yield--Mrs. Mink, did you
want me to yield to Mr. Waxman?
Mrs. Mink. Yes.
Mr. Mica. Mr. Waxman, and I know he has another engagement.
Mr. Waxman. Thank you very much, Mr. Chairman, and I want
to thank Mrs. Mink for allowing me to go forward first with my
opening statement. Unfortunately, I have a conflict. There is
another committee meeting at this very same time, so I am going
to be bouncing back and forth.
But I did want to be here for the beginning of this hearing
to express some of my thoughts. And I, first of all, want to
thank you, Mr. Chairman, because it is important for Congress
to exercise its oversight responsibilities by evaluating
programs to see what changes are needed to improve these
programs.
I have a special concern about this issue, because I was
the author of the Vaccine Compensation Program in 1986. We
enacted this legislation because people were faced with only
one alternative and that was to go into court, a very tough
alternative. It was clearly adversarial to try to establish
sufficient evidence in order to get compensation and then to
establish the damages for compensation. It struck us as an
inefficient way to compensate people who deserve to be
compensated.
The idea was to have a fair and timely, no-fault
alternative to litigation for individuals who suffer vaccine-
related injuries. The program is charged with using the best
available science in developing the table of compensable
vaccine injuries, and it was intended to rely on the advice of
an Advisory Commission on Childhood Vaccines that was to bring
together all the people who have a stake in the system working
effectively.
There were three key reasons for creating the Compensation
Program. These reasons are a good measure of whether it is
working as intended. First, we wanted to compensate children
who were injured by vaccines, which society felt were essential
to public health. Second, we wanted to give parents confidence
that if their child were to be injured by a vaccine, there
would be predictable and generous compensation. In the absence
of such assurance, immunization rates, we felt, were sure to
fall. And, finally, we wanted to prevent manufacturers from
abandoning research into safer vaccines, which is what they did
in the 1980's when the number of such companies dropped from 20
to just 3.
Now, we as a society want immunizations to be available. We
want companies to manufacture these products and to continue to
research how to make these products safer. We thought that with
this vaccine compensation system, we would be providing that
incentive.
I know there had been a long-standing debate over the
timeliness of the program and about the scientific proof
underlying vaccine injuries listed on the vaccine injury table.
We tried to strike an important balance that we thought should
have been respected. Victims of vaccine-related injuries are to
be compensated. Any lawyer or plaintiff will tell you that the
process is less adversarial than litigation, and the CDC
reports that immunization rates are at a record high.
But it is clear this program isn't working perfectly.
Congress has acted twice to change the program, to make it more
no-fault and less adversarial. The administration recently
forwarded recommendations for procedural reforms, which I look
forward to moving ahead with legislatively. And today's hearing
will be helpful in giving us further guidance as to changes
that we need to make the system work as we intended.
There have been disputes about the science and epidemiology
of vaccine injury. We have always erred on the side of
compensating children, if there was a scientific argument that
injuries were vaccine related. At least that was always our
intent--to err on the side of making sure that we compensated
people who were injured.
We have tried to rely on the best available scientific
evidence when revising the vaccine injury table. Injuries have
been added, and injuries have been removed from that table. But
in 13 years, it has never been Congress' rule to second-guess
the scientists. It would be a disservice to the public health
if we were to start to do that today.
At every hearing held this year concerning vaccines, I have
made the point of emphasizing the tremendous public health
value of immunizations. More Americans have been saved by
vaccines than by any other medical intervention. Across the
globe, 2\1/2\ million children die every year from childhood
diseases. Another 750,000 are crippled by these diseases. But
American children are shielded from this death and misery by
vaccinations.
I mention these terrible statistics because I know no one
on this committee would want to discourage American parents
from immunizing their children. But we want to be sure that
when there are rare injuries, we want those children to be
compensated. That is why we enacted the Childhood Vaccination
Compensation Program. It was supposed to be a no-fault, less
adversarial, more efficient way of compensating people so that
we wouldn't push these cases into the courts.
But we left the door open for people to go to court,
because we didn't want them to be precluded from the
opportunity to present their case in a court, if the
compensation system was not working. I want us to see whether
we have accomplished these goals, do what we need to change the
system so that we make it fair to everybody involved. It is
important that the system work. A child who is hurt should be
compensated. The parents of that child who go into that system
shouldn't be faced with all the barriers that they have in a
court system. I have a strong feeling about this compensation
system, and I am hopeful that we can be sure through our
oversight that the program is living up to its objectives.
I am going to be able to review the record. Some of you
will notice that very few Members are here, but the record is
important, and will be available for all of our colleagues and
everyone else to evaluate. I will look forward to reviewing the
record, if I am not here to receive the testimony so that the
totality of the record will give us guidance as to how to
accomplish our important goals for this program.
Thank you, Mr. Chairman, for holding the hearing, and I
yield back the balance of my time.
Mr. Mica. Thank the ranking member of the full committee
for his testimony--actually, for his opening statement, for his
leadership on the issue, and authorship of this Compensation
Program.
I am now pleased to recognize the chairman of our full
Committee on Government Reform, the gentleman from Indiana, Mr.
Burton.
Mr. Burton. Thank you, Mr. Chairman. You can call this my
opening statement and my testimony.
I am pleased that you are holding this hearing today on the
Vaccine Injury Compensation Program. As part of our ongoing
investigation coming out of both this subcommittee and Mr.
Shay's subcommittee, and the issues the full committee
uncovered, there is much to be concerned about within the
Vaccine Program.
No one is suggesting that we do away with vaccines to
protect the public at large. However, we also have a
responsibility to protect individuals and their families as
well. One way of doing that will be to conduct good research in
looking at ways to minimize adverse events with vaccines and to
develop safer vaccines and to inform parents of small children
of possible risks due to side effects.
Now, the chairman said there are rare side effects, and I
may be the exception to the rule, but my granddaughter got a
hepatitis B shot and within 6 hours she was in the hospital,
about to quit breathing, she turned blue, and she was dying--
within 6 hours.
My grandson, the only other grandchild I have, had five
shots in 1 day. He had been perfectly normal up to the time he
was receiving these shots, and now he is autistic. Two out of
two--rare?
We had a man testify before the full committee from
Oklahoma University who said that 50 percent--he is a
scientist, doctor--said that 50 percent of the kids that got
the DPT shot had some side effects--50 percent. Rare? Were the
parents informed about that? Was my daughter informed about it?
For either of her children? Do children really need the
hepatitis B shot between the time they are born and 5 years old
when hepatitis B can only be communicated through blood, sex,
or the mother being infected with it?
Congress as a way of providing compensation--and I want to
tell you, we are going to dig into this--the subcommittee or
the full committee--until heck won't have it.
I mean, I am telling you, parents and grandparents, and
everybody else ought to know the risks of these vaccines.
Granted, they help everybody. They help the society. They have
kept our incidence of major epidemics down to almost zero. But
parents still have the right to know the possible side effects
of these vaccines, and it is criminal not to let them know.
They should have all the information. Lincoln said, ``Let the
people know the facts, and the country will be safe.'' Well,
the same thing applies to medicine.
Congress, as a way of providing compensation, enacted the
National Vaccine Injury Compensation Program, subtitle 2 of
title 21 of the Public Health Service Act, on October 1, 1988.
The Compensation Program is administered jointly by the
Department of Health and Human Services, U.S. Court of Federal
Claims, and the Department of Justice. It was designed as a
Federal no-fault system designed to compensate those
individuals or families of individuals who have been injured by
childhood vaccines.
Now, let me just tell you a little bit about our family,
these two grandchildren of mine. Do you know we can't find an
attorney to take on this responsibility? This is supposed to be
a no-fault system. The chairman of this committee's grandkids
are going to have to fight in court to get compensation in a
no-fault system. Baloney! And I want to find out if the
pharmaceutical companies are behind any of this.
And unfortunately we are hearing heartwrenching stories,
too many to discount, that indicate that this no-fault system
has become emotionally and financially devastating for
families. My staff received a letter just yesterday from a
woman whose child died from the vaccine, and the attorney from
the Government grilled her on everything from how many
compressions she gave her daughter when trying to resuscitate
her to what her educational level was. No fault? Her daughter's
death certificate stated the death was due to recent DPT and HB
vaccines, and she was grilled and grilled and grilled. Why? No
fault?
Why must a parent be subjected to grilling by government
lawyers who are oftentimes cruel in their questioning,
especially when the evidence from the experts clearly states
the death is related to a vaccine? This type of behavior from
Government lawyers must stop, and we intend to make sure it
does stop, if I have to bring everybody from HHS, FDA, and
everybody else up here every day. That has to stop, and the
people that are in charge of these programs, that has to stop.
If there is a legitimate reason for those people to be
compensated, they shouldn't have to go through this. Losing the
child--this woman losing this child is enough pain for her. Or
seeing your child in an incapacitated state, that is enough
pain for them. They don't need to fight this thing out three or
four times in court.
The Department tells us that it typically takes 2 years for
a family to go through the Compensation Program. However, we
are hearing from lawyers and families that the process is often
much longer--4 years, 4 years or more for many, and the
Department sometimes even suggests to families that they just
give up their case. No fault? No fault? This type of attitude
is deplorable! How much money is in that program--$1.4 billion,
one thousand four hundred million dollars.
As I stated at our August 3 hearing, the committee will
continue investigating the various facets of the Vaccine
Program, including the Compensation Program until we can be
confident that, one, vaccines are safe and effective; two, that
there is adequate research in the long-term safety and the
interaction between vaccines; three, that all ingredients and
fillers in vaccines are safe; four, that families and their
attorneys are adequately compensated in a timely fashion; and,
five, that the Government is not keeping families from being
compensated for injuries and death related to vaccines through
administrative changes, through bureaucratic red tape, or
through bullying, and, finally, that families are informed of
the possible side effects and the risks.
And I also want to find out if people at HHS, FDA, or any
of the other Federal health institutes are getting honorariums,
free travel, or any other kind of compensation, directly or
indirectly, from pharmaceutical companies that have a vested
interest in these things being on the market. And to that end,
we have already asked for all the records from the various
people in these agencies to check those out.
Parents should have confidence in their Government and
their health agencies, and they shouldn't have to fight when
their kids are injured by vaccines.
Thank you, Mr. Chairman.
Mr. Mica. Thank the chairman of our full committee for his
opening statement and also personal testimony.
I would like to recognize now the ranking member of our
subcommittee, the gentlelady from Hawaii, Mrs. Mink.
Mrs. Mink. Thank you, Mr. Chairman, and I thank you for
holding today's hearing on the National Vaccine Injury
Compensation Program.
And I concur with the statement just made by the chairman
of the full committee, Mr. Burton. I think that there are some
serious problems in the program and in the way that it is being
administered, and I concur that this committee should undertake
an extensive examination of the problems.
As the ranking member of this subcommittee, I receive a
number of letters from all across the country suggesting the
difficulties that people are encountering. Notwithstanding the
fact that the assumption was that it was to be a no-fault
system of compensation, many of the families affected by the
immunization problems have had enormous difficulty in receiving
their due process.
The Congress has attempted to make various amendments to
the law designed to make it less adversarial, but obviously we
have not gone far enough.
Mr. Chairman, in 1991, one of my constituents filed a claim
with the program on behalf of her deceased spouse who had died
of polio shortly after receiving the Salk oral polio vaccine.
The courts ruled against her; she filed an appeal; the court
rejected the appeal, because the attorney failed to list
objections justifying the appeal. The court did not allow the
attorney to amend the appeal or grant an extension to conform
with this technical objection. The case was dismissed, and the
final irony, Mr. Chairman, is that the petitioner received no
compensation for the death of her husband yet the Government
paid her attorneys fees.
Mr. Chairman, when we established this program, we
envisioned a system in which citizens would be able to file
claims without assistance from attorneys. It does not appear
that this is the system that we currently have. Virtually all
petitioners feel the need to get legal counsel, because the
system is so complicated, and the demand for proof and
connection between the injury and the vaccination is so immense
that the program has been moved into, again, a very adversarial
one, far greater than what the Congress intended.
There are several reform proposals that I believe we should
examine. The statute of limitations, for one. Adding specific
injuries to the table as medical evidence shows that there is a
causal link to the vaccine, and that ought to be extended.
Allowing compensation for the cost of setting up a guardianship
for an injured child, and counseling of the families ought to
be included as part of the compensation.
I would caution against proposals to slash the tax rate on
the vaccines. This is a program that is, I think, well
grounded, and the fact that there is a surplus in the trust
fund I do not believe indicates the lack of necessity for the
tax that is currently invoked; rather, it is because of the
very stringent, conservative manner in which these cases are
processed that the trust balance has now grown to over $1
billion.
So, I would hope that the hearings that we shall be
conducting in the subcommittee as well as the full committee
will underscore the importance of this program, the necessity
of rendering it into a true no-fault process, and granting
these individuals not only the notice that the chairman of the
full committee insists is appropriate but also the compassion
and considerate handling of these cases once they have come to
the Government's attention.
Thank you, Mr. Chairman.
[The prepared statement of Hon. Patsy T. Mink follows:]
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Mr. Mica. Thank the gentlelady.
Now I'd like to recognize Mr. Barr. Did you have an opening
statement? All right.
And we have also been joined by another of our colleagues,
Dr. Weldon, the gentleman from Florida. Did you have a comment
or opening statement?
Dr. Weldon. Mr. Chairman, I want to thank you for
recognizing me. I believe the people who have preceded me have
very eloquently explored all the issues that we are needing to
deal with here.
I just want to thank you for extending an invitation to
allow me to be here as part of this hearing and, as well, the
ranking member for concurring. And I am very pleased to see
that a bipartisan consensus is drawing to the same conclusion
that I have that we need to make changes in the Vaccine Injury
Compensation Program; that it is not working the way its
authors intended it to work, and, therefore, your timing on
this hearing is very critical.
And I yield back. Thank you.
Mr. Mica. I thank the gentleman, and we will have
additional statements added to the record, without objection.
We will now proceed with our first panel, and I would like
to call forward those witnesses.
The first panel consists of Michele Clements who is a
petitioner and mother of an injured child from Milwaukee, WI.
The second panelist is Linda Mulhauser, and she is also a
petitioner and mother of an injured child, and she is from New
York City, NY. And our third panelist is Mr. John Salamone,
president of Informed Parents Against VAPP. We have those three
witnesses.
This is an investigations panel and oversight subcommittee
of Congress. We do swear in our witnesses, so if you would
remain standing, raise your right hands.
[Witnesses sworn.]
Mr. Mica. Thank you. Witnesses answered in the affirmative,
and I think these three panelists can give us some insight as
to their personal experience with the compensation fund. I
might say that we try to limit each of our oral witness
testimonies to 5 minutes. If you have additional lengthy
statements or other documentation you would like to have
included as part of the record, I would be glad to do that by
unanimous consent.I21We do have a request from Michele
Clements, our first panelist, for presentation of I think
approximately a 1-minute video. Is that correct?
Ms. Clements. Correct.
Mr. Mica. Without objection, we will also allow
introduction of that video.
I would, with those comments, then, like to recognize
Michele Clements, our first panelist.
STATEMENTS OF MICHELE CLEMENTS, PETITIONER AND MOTHER OF
INJURED CHILD, MILWAUKEE, WI; LINDA MULHAUSER, PETITIONER AND
MOTHER OF INJURED CHILD, NEW YORK, NY; AND JOHN SALAMONE,
PRESIDENT, INFORMED PARENTS AGAINST VAPP
Ms. Clements. Thank you, Chairman Mica and----
Mr. Mica. Did you want to show that first?
Ms. Clements. Pardon? Yes.
Mr. Mica. OK. Then we will just go ahead and show that
video.
[Video.]
Ms. Clements. I don't hear the sound to it. Basically, this
is the beginning of Andrew's day and starting out with his
medicines, his feeds, and things like that. And I think all we
are going to see is the starting of his feeds.
[Video.]
Ms. Clements. I do this on average maybe--not maybe, but
four times a day, but I also give him medications the same
way--through his stomach. So, on average it is about eight
times a day I have to feed him or medicate him through his
stomach.
Mr. Mica. If you could proceed with your testimony.
Ms. Clements. OK, thank you.
Mr. Mica. And you might pull that mic as close as you can
so we can hear you. Thank you.
Ms. Clements. OK. Once again, I want to thank you, Chairman
Mica and the members of the committee, for allowing me to share
my son's life and my life as to what happened after he was
vaccinated.
The day I found out that I was pregnant was a great joy. We
couldn't wait for his entry into this world. It took us 3
months to pick his name, because it was something we wanted him
to be proud of throughout his life. Strong, kingly and manly is
the meaning of his name. On January 31, 1992, he entered this
world a healthy, beautiful baby boy. We wanted the best for him
as we did for our other son, Michael.
We don't allow smoking, drinking or drugs in our home,
because we want a safe and healthy environment for our
children. We took our sons to the doctor for their well care
checkups as scheduled and vaccinated them, because it was the
best way to protect them from life threatening illnesses. We
didn't know about all the adverse reactions that can come with
vaccinating our children.
On August 6, 1992, we were thrown into a world that many
experience but few know little about: the horror of what the
DPT vaccine can do to some children.
My husband, Scott took 7 month old Drew in for his checkup
and the third DPT shot. I asked my husband to make sure the
doctor gave Drew a check-up to see that all was well with him
before he got his shots. I called Scott from work after the
doctor's appointment to find out how Drew was doing. My husband
explained that Drew had been sleeping since his shots and I
thought, good, because after Drew's second DPT shot he had
cried for a very long time.
When I got home from work, Scott told me that Drew had been
sleeping most of the day and was still sleeping. Scott went to
work and I woke up Drew so he could eat, but he went back to
sleep again. When Scott got home from work later that night, he
was passing our boys' room when he heard a strange, rasping
sound coming from the room. He checked on Mike, who was fine,
and then realized that the sound must have come from Andrew's
crib.
When he got to Andrew's crib, he had the shock of his life.
Our little boy wasn't breathing and he was as pale as a China
doll. Scott yelled for me to come and asked me, ``What is
this?'' All I saw was my baby laying in his father's arms as
limp as a rag doll and as white as a China doll. I ran
downstairs and grabbed the phone and dialed 911, but I was in
such shock that I forgot my address and street name.
Scott followed me and handed me Andrew, and I realized for
the first time that my baby wasn't breathing. I did CPR on him,
and after the second breath I gave him, he took in a deep
breath himself. The color came back into him and he appeared to
be sleeping.
The fire department came. Half of the men worked on Drew
while the other half followed me to the boys' room. I showed
them Andrew's crib and the puddle of fluids we found him lying
in. One fire fighter told us that he believed that Drew had had
a convulsion. He said Drew was very warm and asked for some ice
bags to cool him down. They told us Andrew would have to go to
the hospital.
Andrew was transported to the hospital in an ambulance, and
by the time he got to the hospital, he was in the middle of
another violent convulsion that was so bad they wouldn't let me
in the room with him. Finally he stopped convulsing and the
doctors explained that this may be the only time he convulses,
and it may never happen again.
One month later, he was crawling on the floor when all of a
sudden he collapsed and began to jerk his arms and legs while
his head went backward and his neck stiffened. I grabbed him
and told Scott to call 911, and at the hospital they explained
to us again that sometimes children have seizures and they grow
out of them.
Between the ages of 6 months and 3\1/2\ years old, Andrew
had 84 seizures, the shortest being 15 minutes and the longest
being 1\1/2\ hours. Almost always, Andrew would run an
unexplained fever with the seizures even though he wasn't sick.
One doctor told me the fevers he ran with his seizures was
because his body's thermostat had been damaged, and his body
could not regulate his temperature like it should.
Still, with all those seizures, the miracle was that Andrew
learned to walk and talk. At 3, he could count up to 20; he
knew his colors and shapes. We learned to live with his
seizures even though we always lived in fear that 1 day he
would have a really long seizure that would damage our bright,
loving, intelligent little boy.
On the night of September 8, 1995, our worst nightmare came
to life when Andrew went into a seizure that lasted 4\1/2\
hours. Standing by helplessly as our son seized for 4\1/2\
hours while his temperature climbed to 108.8 degrees is an
experience no parent should ever have to go through. When
Andrew finally stopped seizing, we were allowed to see him in
the ICU. To our horror, we saw a child double the size he was
when he came into the hospital. When we asked what happened,
they took us out of his room. At 7 a.m., a doctor told us that
Andrew's kidneys and liver were failing.
When we finally got to see our son again, he looked like
another child. We couldn't hold him, because he had a dozen
tubes hanging off of him. A special bed rotated his body,
keeping his body at one temperature and massaging him all at
the same time.
At 9 a.m., we were told by the doctor--and I will never
forget those words--we were told: ``Your son is dying, and so
that you understand what I am saying, he will die before 12
p.m. If you want to see him alive, you better call anyone who
wants to see him now. Here is a phone you can use. Are you OK?
Mrs. Clements, are you all right?''
Not knowing what to say, I said ``No, not my baby'' over
and over again. ``He didn't go through 84 seizures to die. God
has a great use for his life. He didn't bring him through all
these seizures to die now.''
Every organ in Andrew's body was damaged and was
functioning at only 10 percent. Andrew didn't die that day as
the doctors said he would. By the grace of God, he hung on to
life. On September 11, Andrew slipped into a coma.
Andrew was in the hospital for 4 months while we waited for
him to come out of his coma. During that time, I called our
lawyer, Victor Harding, to tell him what had happened. Mr.
Harding was representing Andrew in the U.S. Court of Claims
which hears vaccine injury compensation cases, and he told us
that the Government had offered us $350,000 to take care of
Andrew.
All I could think of was how unfair it was. My son is
fighting for his life. He may die, and if he lives, we don't
know what kind of condition he will be in. And the Government
is telling us that all Andrew is worth, if he lives, is
$350,000. That amount isn't going to begin to be enough to care
for a severely brain injured child for the rest of his life. I
told our lawyer, ``You can tell those Government lawyers where
they can file that offer.''
As you can see, Andrew did live. He fought bravely to live.
Andrew is a hero, and now it is my job as his mother to fight
for him to have the best kind of life that I can give him.
Andrew can't walk or talk; he can't eat or drink; he has to
be fed through a tube in his stomach. Sometimes we give him
tiny tastes of food. I will put a drop of apple sauce or
pudding on the tip of my finger and put it on his tongue, but
it can't be too much or he could choke because he can't swallow
properly. His body is 7 years old but his brain is that of a 3-
month old.
I was a good parent. I did what the Government and doctors
told me to do, and I gave my son the DPT vaccine. And now he is
crippled. His life has been sacrificed, and instead of being
treated kindly and fairly by the Government's Vaccine Injury
Compensation Program, we have been treated unkindly and
unfairly.
You may be wondering how we found out about the Vaccine
Compensation Program. It wasn't from anyone in the medical
field. We found out from a stranger who had heard about what
happened to Drew. Her son died from the DPT vaccine. She
referred us to a lawyer and sent us information about the DPT
vaccine.
Reading the information, I felt like I had just been
transported into another world, a world that I didn't believe
could exist in our country where the Government keeps such
information from us that could help us protect our children
from becoming retarded. I didn't know that when Andrew screamed
for hours after his second DPT shot at 4 months that it was a
warning sign that shot might not be good for him. I didn't know
that in 1992 there was a safer DPT shot called DtaP vaccine
that causes fewer reactions. I wish Andrew had a chance to get
the DtaP vaccine instead of the DPT.
When we met with our lawyer, Victor Harding, he told us
about applying for the Vaccine Injury Compensation Program and
what to expect from the Government. He said that a lot of
children like Drew are denied compensation or offered so little
money that it wouldn't be enough to take care of him for the
rest of his life. Like I said earlier, when my son was on what
we thought was his death bed, the Government offered us
$350,000. We turned it down and proceeded to the next step.
We had to fly to Washington, DC, for our compensation claim
hearing in the winter of 1998. My stomach was full of
butterflies when I gave my testimony about what happened to
Andrew on the night of August 6, 1992. I stayed for 5 hours of
the 10 hour hearing and then went back home to care for my son.
My lawyer was there for the second half of the hearing on the
following day.
In the end, the Government turned Andrew down for
compensation. There would be no money to help us care for our
son. The Special Master told us that if we had applied for
compensation a year earlier, she would have found in our favor
but because of the table change, there was nothing she could do
but find in favor of the Government.
That angered me, and it still does anger me that this table
can be changed by the Government after Congress put the table
in the law to help children like Andrew get compensation. That
table change sure wasn't for the betterment of the families who
go through horrific life changes due to vaccine injuries. The
Government forces us to give our children these vaccines and
then when something goes wrong, too bad, you are on your own.
The Special Master told us to appeal, but where is the
logic in doing that if the rules are still the same? We will
take our chances with the vaccine manufacturer in court.
Because if we don't, what is going to happen to Andrew?
The doctors told us Andrew could live to be 25 or even 40
years old. We want to care for him as long as we can. We don't
want him to be put into an institution where they won't do for
him like we can do for him. To care for him the right way, our
home needs to be wheelchair accessible, and we need a lift to
get him into a van, and we need to be able to afford to buy all
the medications and supplies he needs after he turns 18 years
old. We just want enough money to care for him the right way,
because no amount of money could ever really compensate Andrew
or us for what the DPT shot took from him.
Once again, thank you for listening to what has happened to
my son and our family, and God bless you.
[The prepared statement of Ms. Clements follows:]
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Mr. Mica. Thank you for your testimony, and I would like to
now recognize Linda Mulhauser, who is a petitioner and mother
of an injured child from New York.
Mrs. Mulhauser, you are recognized.
Ms. Mulhauser. Thank you.
My son Stephen is sitting in front of me so that he can do
as much lip reading as possible, and I am wearing an FM
microphone to help elevate my voice for him. The interpreter
was not available for today's meeting.
Chairman Mica and members of the Government Reform
Committee, thank you for your invitation to appear at today's
hearing to tell of our family's experience with the Vaccine
Injury Compensation Program.
Our son, Stephen, now 17 years old, was seriously and
permanently injured by a DPT vaccination at 3\1/2\ months of
age. Born healthy and full-term by natural childbirth, Stephen
received the highest Apgar score ratings of 9 and 10. At 7
weeks of age, Stephen received his first DPT vaccine. We were
reassured by his pediatrician that the swelling at the
injectionsite, among other changes we noted, was only a mild
reaction and of no concern.
Following the pediatrician's advice that the benefits
outweighed the risks, Stephen was given and reacted severely to
his second DPT shot with over 9 hours of high-pitched screaming
and high fever.
During the next couple of days, Stephen's eyes began
wandering independently of each other and then spasm. He could
no longer roll over or reach out to play with his crib gym,
because his hands were fisted and held at his shoulders.
Over our concern, Stephen was then given his third dose of
DPT vaccine in half doses at 5\1/2\ and 6\1/2\ months of age.
His pediatrician said that he must have this vaccine in order
to attend school.
We later discovered during our compensation hearing that
from the day of the second shot in 1982, Stephen showed failure
to thrive as his charted growth plummeted. Stephen's brain had
all but stopped growing during the time period he was receiving
his DPT vaccines. He remains affected with fine motor and gross
motor difficulties, posturing, language-based learning
disabilities, visual perception issues, behavioral problems,
and profound bilateral hearing loss. He requires special
schooling, assistance with simple daily living skills, constant
adult supervision, and numerous therapies.
Having your child injured by a vaccine that is supposed to
protect him is devastating. Our experience of going through the
compensation system only added insult to that injury. After 5
years of preparation for a civil suit through depositions,
ready for trial, our attorneys informed us that they had become
obligated to advise us to put a stay on our case and apply for
Government compensation prior to a 1990 deadline date. It was
supposed to be a simple and expedient process, taking about 18
months, with decisions to be made by special masters without a
trial. We were advised that we could go back to the lawsuit if
the desired outcome was not reached.
Nine months later, we had our hearing in a New York Federal
courtroom, requiring preparation and giving of testimony,
including cross examinations. Expert witnesses were called for
both sides. Two months later, the special master determined
that Stephen was in fact injured by the DPT vaccine, as
described within the guidelines of the vaccine injury table.
Although we considered this first step of the process to
have been timely and professionally managed, it seemed only to
lack a jury to be a traditional court trial.
The next step of the process was to determine an amount of
money to be compensated. We already had a life care plan in
place, because we were ready to go to trial before entering the
Compensation Program. Instead of working with us to determine
Stephen's appropriate life care needs, the Department of
Justice's attorneys sought for years to trivialize the extent
of Stephen's vaccine injuries and to argue for irresponsibly
insufficient funds to support a reasonable quality of life.
After 4 years of such negotiations, we needed to request
another hearing to come to settlement requiring further
testimony from ourselves and Stephen's life care planner. It
was determined on the spot by the chief special master that the
life care plan the DOJ's attorney and life care planner
submitted was indeed unrealistic and ordered specific actions
to be completed within 2 months.
This hearing in and of itself, again, was handled
professionally. However, 2 months turned into 4 before an
agreement was signed. Further delays ensued to correct a
significant math error relative to the initial payment. The
agreement was then filed at the end of the 90-day filing
period. The stipulation then required that we become legal
guardians of our own child, causing further delay before any
checks would be issued by the annuity company.
From the time we applied to the Vaccine Injury Compensation
System to the time we were finally able to access the funds,
6\1/2\ years had gone by. Our savings disappeared as we paid
for therapies not covered by our insurance, hearing aids, and
special schooling, among other extraordinary expenses. Under
the guidelines of the program, families are not reimbursed for
any past expenses.
We were very fortunate in that the law firm who represented
us continued to fight on Stephen's behalf far beyond any
financial gain. In fact, the single payment of $30,000
allocated for attorney's fees in pre-1988 cases only covered
the expenses incurred in preparation of our two hearings. The
law firm itself received nothing for its efforts of
representing Stephen over a 10-year period.
Our attorney has described the hearing process as a ``full-
out liability case.'' Once our case was won, he then had an
item-by-item fight to obtain even the smallest of needs on
Stephen's life care plan. Concessions were only made on small
items. Much time was spent by the DOJ attorney forcing the
discussion of petty matters, such as whether Stephen would
benefit from the use of a $10 special needs doorknob--one was
allowed throughout his lifetime--rather than getting down to
serious matters dealing with the quality of Stephen's future.
Deadlines were often extended.
In our view, the recommendations of the DOJ attorney and
Government life care planner assigned to our case were
unrealistic and irresponsible. For example, to determine the
value of residential care, they specified a residential center
only in its planning stages or a charitable group home with no
day services and a wait list of over 1,500 persons. We were
given a ``take it or leave it'' final offer, which still did
not adequately address Stephen's needs. This prompted our
request for the second hearing, which took place 10 months
later.
We entered into negotiations for Stephen's life care with
the belief that, unable to support himself, his needs would be
met, and his future would be sufficiently secure so that he
could live as independent and normal a life as possible. We
were mistaken. Our experience was a totally exhausting and
extremely adversarial process of nickel and dime arguments.
On the Government's behalf, every effort was made by the
DOJ attorney to hold on to as much of the fund as possible.
This included an attempt to establish a reversionary trust
requiring any moneys not spent during the course of each year
to be returned to the Government. Such practices place at risk
the future care and security of every vaccine-injured child.
The DOJ attorney continued to act as if he was still
fighting a case, attempting to minimize the award which he had
previously fought to avoid. This conflict of interest
deadlocked negotiations and added years to resolving our
settlement. After a decision is given that a child should be
compensated, DOJ attorneys should step aside and allow others
with input from life care planners and families to determine
the projected needs of the individual throughout the balance of
their lifetime.
As compensation is not retroactive to the date of the
decision, each additional year of bargaining is 1 less year to
be compensated. This places further undue hardship on already
emotionally and financially strained families. Our perception
is that the program relies on this tactic to force families and
their attorneys to accept less than adequate settlements, which
would provide optimal treatments for their vaccine-injured
child. Once the determination has been made that an adverse
reaction was incurred, both sides should be working together in
the best interest of the child.
The all out effort, time, and expense required to
successfully negotiate the Vaccine Injury Compensation Program
prompted our major law firm to never accept another vaccine
injury case.
We are further concerned that life care plans used to
determine settlement amounts are forwarded to annuity or trust
companies with the stipulation labels remaining. In our
experience, copies of the life care plan have also been
requested by courts and banks. A child's needs will inevitably
vary. Type or frequency of therapies can and do change. New
treatments become available. Labels remaining on life care
plans used to determine payment schedules leave open a real
risk that at any time someone might withhold funds if moneys
aren't spent specifically as tagged. We are extremely
uncomfortable that an individual as far removed as a bank clerk
can potentially have a say over Stephen's care, because a
treatment is not listed on his life care plan.
Every family who has gone through this system faces the
same threat to their child's welfare. Might I suggest that such
labels be removed in the future before sending out the plan and
that a letter be issued to clarify the ability of legal
guardians to utilize funds in the most appropriate manner for
the injured individual in their care.
As parents, we did everything in our power to provide the
love, nurturing, and care to ensure a bright future for our
first-born child, a life full of dreams and promise. Part of
that care was to protect him from harm and life-threatening
diseases. We believed we were protecting our son when we took
him for his baby shots. Instead, his life and ours have been
changed forever.
Each day is a challenge, and we try to meet that challenge
to make things a little better. My hope is that by our presence
here, today's challenge will make things better for the many
families of vaccine-injured children who are in or who are
attempting to enter into the Vaccine Injury Compensation
System, and for those who have been rejected by the system
following changes to the vaccine injury table.
Thank you for the opportunity to share our experience and
to express my concerns.
[The prepared statement of Ms. Mulhauser follows:]
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Mr. Mica. Thank you for your testimony. We will withhold
questions until we have heard from all the panelists.
Next is Mr. John Salamone, and he is president of Informed
Parents Against VAPP.
You are recognized, sir.
Mr. Salamone. Thank you, Mr. Chairman, members of the
subcommittee. I appreciate the opportunity to talk with you
today regarding legislative and policy options for improving
the Vaccine Compensation Program.
Before offering specific testimony concerning outlined
areas for improving this program, I would like to state for the
record that I have served as vice chair of the HHS Advisory
Commission on Childhood Vaccines and currently serve as an
unpaid consultant to the Subcommittee on Vaccine Safety for the
National Vaccine Advisory Committee.
But more importantly, I am the father of David, a 9-year
old with polio contracted from the oral polio vaccine. As
David's dad and as president of Informed Parents Against VAPP,
also known as IPAV, a group of families who suffer from oral
polio vaccine injuries, I worked long and hard with
immunization advocates to move this country toward an all-IPV
schedule or a killed virus schedule.
I am a supporter of immunizations. I have seen first hand
in my life the diseases that we can now prevent and believe
that we must maintain a strong immunization system--the safest
one possible. With my son and others in IPAV having paid a huge
personal price for mass immunization, I have also become very
familiar with the National Vaccine Injury Compensation Program.
The first topic I was asked to address concerns changing
the adversarial nature of the Compensation Program procedures
and the hearing process. Given the choice between the program
and personal injury lawsuits, the program wins. However, there
is room for improvement. In their current form, the procedures
are at times adversarial and need to become more user friendly.
Some suggestions to improve the process include:
reevaluating the procedures to take into account the literacy
level of most applicants. In its current form, either on the
website or in the information packet, the language cites legal
requirements and can often put off those unfamiliar with such
legal terms. In short, put it in plain english.
Provide simple and clearly defined steps an applicant must
go through in order to be considered for an award. This will
assist applicants in working through the process and lead to a
better understanding on their part of what their
responsibilities are.
It would be ideal if new applicants could be provided with
a counselor who can provide support through the application
process. Most of the families who are dealing with vaccine
injuries are simply too overwhelmed. They need the kind of
assistance that comes from a person, whose job description
includes compassion as a requirement.
The counselor can be empowered to provide references where
applicants can get legal aid. Perhaps a bar association or
other third party group can be asked to provide this special
and much needed service.
The second area is reforming the evidentiary and
adjudicative standards for determining compensation. From my
experience and those of our families, I feel that the
evidentiary stage is generally fair and runs smoothly for most
applicants.
An overall comment, however, is that the government trust
of $1.4 billion is guarded too well. The coffers need to be
opened to provide the kind of humane service people in vaccine
injury situations not only need but deserve. For example, the
damages phase, to use the common term, can become more flexible
in allowing for special circumstances. We have had families who
have gone bankrupt trying to meet their children's medical and
emotional needs while going through the system.
The Government can also provide greater clarity with regard
to future lost wages. Some suggestions that come to mind
include: administering intermediate funds to those in need
based on good faith and a reasonable basis for claim; including
family counseling expenses and reasonable fees and costs
associated with the establishment of a guardianship or
conservatorship; extending the current statute of limitations
from 3 years for injury claims and 2 years for death to 6
years, and creating a specific method or formula for
calculating lost earnings under VICP that is easily adaptable
for individual use.
The final area of review is ensuring the level of funding
to meet future needs. Current funding is not in jeopardy and
should certainly be maintained. As future vaccines are created,
these need to be added automatically to the injury table with
assignment of appropriate excise tax. Let me repeat: It is not
about funding; it is about access to funds for those who need
it. If greater funds would equate to better services for
applicants, then I would say, yes, provide more funds earmarked
for those services I outlined earlier. If the committee takes
action that will enable larger awards, then the criteria for
what is covered under an award would need to be re-evaluated.
I firmly believe in the VICP. It has done the best job it
can under its current design to fulfill its purpose. I have
been impressed with the dedication of those I have worked with
in the program over the past 6 years. I believe, though, that
even they would admit that improvements can and should be made
to ensure that this program, which has served us well for a
decade, can continue to meet the needs of those who sacrificed
themselves for a universal vaccine program.
Thank you, Mr. Chairman.
[The prepared statement of Mr. Salamone follows:]
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Mr. Mica. Thank you. Thank all of our witnesses for their
testimony this morning.
I have a couple of questions, if I may.
First, Mrs. Clements, I think you have been denied
participation in the fund because of the original injury table
being changed, and I believe you testified you felt this is
grossly unfair. What would you recommend as far as a process
that you think would be fairer, and, again, what about
individuals like you who have been denied the opportunity to
participate because of these changes, you think that Congress
should take some remedial action to allow your participation?
Ms. Clements. Basically, when we first applied for--when I
first got information on the adverse reactions, I got the
papers, and my son fit the--if you want to say qualified--for
getting compensated. Then, as I said, the table changed, and
all of sudden there is just no one, basically, it sounds like
could possibly be compensated because of the way they changed
this table.
And if they could put it back to the way it was, more
families could be compensated or make it, as Mr. Burton said,
stop making it impossible and stop making it where we have to
go in and fight to prove that our child reacted. When my son
reacted in 15 hours to it, and we have 72 hours at that given
time when we first started that if he seized within 72, it is a
reaction from the DPT shot. Then all of a sudden it is no
longer on the table.
I had a great problem with them taking the seizures off the
table, because I know a high percent of reactions are seizures
from the DPT shot, and that, to me, just showed a sign of
saying, ``We don't want to pay anyone anymore, and we can get
rid of this section of people or children that react,'' and if
they could just look into it deeper and, like Mr. Burton said,
investigate it in the long-term and not do a couple weeks, a
couple months study, because our children are getting these
shots up until possibly 6 years old, and we don't know what can
happen at 6 months. The friend of ours whose child died, died
at the fourth shot.
So, the other thing of giving warning signs, my son had two
prior warning signs to it, but because my doctor and a lot of
doctors don't tell us these adverse reactions, I didn't know.
My son may not be in this condition if I would have known that
the, if you want to say, the junkiness that developed after
the--when he was 2 months old.
He had a rattle in his chest, and I kept going to my doctor
saying, ``Something is wrong. Something is wrong'' right after
he had his DPT shot, and I was given the normal of ``Well,
newborns make that sound.'' I go in for the 4-month old, and he
does the excessive crying. And I am not told that is an adverse
reaction, so I go in with the 6-months, and now I have a son
who has a seizure disorder and ultimately puts him in this
condition. Now, I could have been--that could have been
eliminated if I would have known the warning signs ahead of
time.
So, it is something to make sure that the doctors are
forced to give out that information, that it is not a--well, as
I view it--a cover up or a hiding, to go into a long study of
what is going on with children that react, because some
children don't react on the first one.
Mr. Mica. Have you had access to any other legal remedy?
Have you pursued a suit against the manufacturers or----
Ms. Clements. At this present time, our lawyers are looking
into the steps of--or looking into going after the
pharmaceutical company themselves. They figure there are ways
of going after the manufacturers.
Mr. Mica. To date, to deal with the problems you have
incurred, how have you had to deal with that financially--just
all your family resources or some other----
Ms. Clements. Originally, when Andrew started out with his
seizures, it was financially coming through us, and then we
were told that we could go and apply for SSI, and that would
help take care of the medical bills and things like that. So,
probably within a few months, about 6 months we had to wait,
and then SSI kicked in, and it started paying the bills. But,
originally, we paid the beginning of those bills for probably
the first 6 months of his reacting to it.
Mr. Mica. Ms. Mulhauser, it took you, what is 6\1/2\ or
7\1/2\ years to receive compensation?
Ms. Mulhauser. It took 5 years to finalize all of the
stipulation. It took another year and a half to go through the
court system to establish legal guardianship. So, the annuity
company would not release the checks until we had proof of
legal guardianship, and it was a process we couldn't start
ahead of time, because the guardian courts required the
stipulation to be filed.
Mr. Mica. Based on your experience, how can we speed up
this process?
Ms. Mulhauser. Like I testified earlier, I believe that if
both the Government and the parents come to the table with the
child's best interests instead of fighting over the cost of one
item or another or whether it is going to cost $5 or $10, the
process would speed up quite a bit.
I think we could have taken 3 years off of our compensation
time just by letting the life care planners who are qualified
to determine life care needs, with the doctors' reports, the
educational reports, the parent input--there are plenty of
resources that are available that a mediator, say, who
specializes in the life care planning of individuals with
disabilities, could bring that process to a conclusion much
sooner than having high-priced lawyers arguing over items.
Mr. Mica. Thank you.
Mrs. Mink.
Mrs. Mink. Thank you, Mr. Chairman.
The testimony of all the witnesses on this panel is very,
very provocative, and I hope will be utilized to encourage this
committee to make some very important changes to the existing
law.
Mrs. Clements, what bothers me in the situation that you
found yourself in, with respect to the symptoms that occurred
immediately after the shots were given to your son, that no one
explained to you at that point that those were suggestive of
adverse reactions to the vaccination and that you relied on
your physician to be able to make an appropriate reading as to
what was going on inside your child's system.
I take it from your testimony that your physician did not
provide you with such a forecast or analysis of what was going
on. Is that correct?
Ms. Clements. Correct.
Mrs. Mink. Then it seems to me for the compensation system
to insist that you as a parent, non-medical professional, be
able to make a decision to halt the Vaccination Program, which
the Government was insisting that every child have, is
perfectly illogical. There is no reason for a parent to know
when to insist that the Government stop the vaccination
procedure. The physicians, on the other hand, have the
knowledge and the training, or should have, and be able to make
those decisions. Don't you agree?
Ms. Clements. Yes.
Mrs. Mink. So, given that circumstance, it would seem to me
that one of the things that the committee should look at is the
responsibility of the medical profession in each of these
cases. Warnings should have been given. The medical profession
should exercise sound judgment, and in the absence of
exercising that sound judgment, compensation should be
automatic. I mean, that is my general feeling.
And to hear your testimony that such technical things as a
statute of limitations, that your filing was 1 year late, or
that the technicalities of the table had changed so as to
disqualify your claim is absolutely unacceptable in tort law.
I happen to be a lawyer. It is always the incident of the
injury that establishes the date of the claim. It was through
no fault of your own that you were not apprised of your ability
to stop this injury from occurring and becoming more serious.
The compensation concept of the Federal Government should be an
automatic processing of the claim, because certainly there
could be no other justifiable reason for your child being in
this serious condition that he is in. The medical profession
acted inappropriately and this injury could have been
prevented.
And given those circumstances, the compensation approach
should be categorically in your favor, since there could be no
possibility of negligence on your part. It is not the case of
trying to find blame on the medical profession, but certainly
to deny compensation in your case goes against all semblance of
justice and equity in this country.
So, I would hope that the committee would be able to take
your testimony and your statement and correct that. And
certainly with respect to the timeframe, the Government should
have a statute of limitations where if they fail to act within
a reasonable time, that the compensation claimed by the
victim's family ought to be automatically adjudicated by some
third party.
I think that since the Vaccination Program is one that is
imposed by the Government for the public safety, that we ought
to impose upon the Government strict regulations with reference
to the protection of the parties involved, and, Mr. Chairman,
those are my views.
Thank you.
Mr. Mica. Thank you.
I would like to yield now to the chairman of our full
committee, Mr. Burton.
Mr. Burton. Thank you, Mr. Chairman.
I am not going to ask but one question. I have to leave to
go to a luncheon, but I will be back for further--for another
part of this hearing.
I want to express to the parents my sorrow and all the
parents across the country that have experienced what you have.
I have similar feelings for my grandchildren, and may the good
Lord bless you and your families for what you have gone through
and what you are going to go through the rest of your lives.
I would like to just make a couple of comments. The reason
that this fund was set up, as I understand it, is because the
pharmaceutical companies were concerned about massive lawsuits
and how it might adversely impact their industry and how many
of those pharmaceutical companies smaller in nature, and even
the large ones, might go out of business if excessive lawsuits,
because of adverse reactions, occurred.
And, so the Government and Mr. Waxman justifiably sat down
with them, and said, ``OK, we are going to work this out so
that there is a non-adversarial process that will take place
where people will be compensated fairly, and you will still be
able to protect the pharmaceutical companies.'' And this fund
of 75 cents a shot was established to take care of that.
Now, we find it is an adversarial relationship; that people
have to fight to get that money; they can't get lawyers to take
their cases--and I know; I am speaking from personal experience
now. We can't find many lawyers that even want to look at this.
So, this adversarial relationship that has been created should
not be happening, because that was not the purpose of the fund.
Now, some people have said to me privately that they are
concerned that even though we have $1.1 billion in that fund,
that the fund may be depleted if they aren't very careful.
Well, my view is if it is a non-adversarial situation we are
looking for, then if we have to increase the cost per shot to
$1 or $1.50, double it, to make sure that these people are
adequately compensated for the tragedy that they have to
endure, then we should do it. But there should not be this kind
of a problem.
And I intend to be back for the gentleman who works for the
fund and the people at the Justice Department, because I am
sure Congress didn't intend that, and if they are trying to
protect that fund, then that is baloney. We can always raise
the amount. And I am not for tax increases, but I am for making
sure that people who suffer like these people have suffered are
fairly and adequately compensated, because it wasn't their
fault that this happened.
The second thing that concerns me is that my son-in-law is
a doctor, and I have talked to him about this, obviously,
because it is our family that is involved. And I ask him about
shots, and he says, ``Well, we get guidelines from the Food and
Drug Administration and from the Health and Human Services, and
unless it is approved by the FDA, then, you know, I am very
careful, and I don't--'' So, they rely--the doctors rely, in
many cases, probably in most cases, on the judgment that is
coming out of their associations, which is coming from the FDA.
And, so if we are not getting enough information, then it seems
to me that the Government health agencies must be more
forthcoming to the physicians so that they could be more
forthcoming to the patients so that everybody will know the
risks involved.
That hepatitis B shot that my granddaughter took, that
almost killed her, would not have been administered had I known
the risks or my daughter knew the risks. My grandson got five
shots in 1 day. You know, sometimes I think it is an overload
of the system, like if you put too many plugs into an
electrical socket, you are going to blow the breaker switch or
you are going to--if you have an old-style home, you are going
to have the fuse blown. And we are loading these kids up with
25, 30 shots between the time they are born and they are 5 and
6 years old before they go to school. And we need to know from
HHS and FDA and our health agencies, through our doctors, what
the risks are, and the parents need to know that so we minimize
the kinds of problems we are talking about here today.
So, those are my views. I think I would just like to ask
you, Mr. Salamone one question, and your son suffers from the
polio vaccine, the live polio vaccine. You were talking about
making sure that dead viruses are used. Now, is there any
indication from your research or from talking to scientists and
physicians that if we use dead viruses that the risk is
minimized even though they may get several vaccines?
Mr. Salamone. The only cases of polio in the United States
for the past 20 years have come solely from the oral polio
vaccine.
Mr. Burton. The live vaccine.
Mr. Salamone. That is right. And, so in answer to your
question, I don't have any information to indicate anything
specific regarding the killed virus, but I guess the facts are
that polio in the United States, while we think that it has
been eliminated, in reality, we have been creating it by the
very vaccine designed to prevent it, and that was the oral
polio vaccine. And I am pleased to note that as of January
2000, they are recommending now--the CDC is recommending that
the oral polio vaccine no longer be part of the regular
vaccination schedule finally after 5 years, I might point out,
of a lot of testimony.
Mr. Burton. And I wonder how many people suffered. Do you
have any idea how many people----
Mr. Salamone. Well, on the books, they say between 8 and 10
a year, but, quite candidly, virtually every family that we
deal with has been misdiagnosed. And in the case of my son, it
took them almost 2 years to finally put the pieces together and
figure out that he didn't have half of his immune system, and
that is why he got polio as a result of the vaccine.
Mr. Burton. If I might ask just another question of this
witness, Mr. Chairman.
So, the people from HHS and the people from the health
agencies have known for how many years now that the live virus
caused this problem?
Mr. Salamone. Oh, I venture to say that the health industry
has known for decades that you can get polio----
Mr. Burton. Well, let me--my time is running out. So, they
have known it for decades, and there was an alternative to
that--the dead virus--that could have prevented polio, is that
correct?
Mr. Salamone. That is right. A safer, killed virus was
available.
Mr. Burton. And yet they went ahead and let the American
people take the more dangerous virus for, you say, for at least
a decade or so.
Mr. Salamone. It was just a bad, old habit that went back
to those days decades ago.
Mr. Burton. Well, I am not so sure. And one of the things
that we want to investigate is whether or not the
pharmaceutical companies, who have a huge investment in this,
have influence or undue influence on the departments of health
in this country. If you know that a virus that is live causes
this kind of damage to a young child, whether it is polio or
anything else, and if they continue to use it when there is an
alterative--for instance, the DPT shot is still being used
today, and they have a DPaT shot that is safer, and when I
asked people at the hearing we had not long ago, they could not
explain to me why the DPT shot is still being used. The only
thing that pops into my mind is there is money involved, and if
there is money involved, why are HHS and the FDA allowing that
to continue to be used? And, so we are going to check all that
out.
It sounds like a similar situation with the polio virus
vaccine. We are going to look into all that, and we are going
to get the records of all the people who are in the
decisionmaking process at the health agencies; we are going to
get those records. We are going to go back and find out where
the money came from when they go to speak. We are going to go
back beyond the organization that puts the meeting together
where they speak and find out if the pharmaceutical companies
are underwriting all that and if they are paying honorariums
for these people. And if that is going on, there are going to
be some changes made in the way HHS and the FDA do their
business. And we are going to check everybody out, everybody.
Mr. Mica. Thank the chairman.
If I may, Mr. Kucinich, can I recognize Dr. Weldon, and
then I go to you? Would that be acceptable? Thank you.
Dr. Weldon.
Dr. Weldon. Thank you, Mr. Chairman.
Ms. Mulhauser, I was looking at your resume. You had a
career in fashion design prior to your son's illness coming
along, is that right?
Have you been able to work in that field at all or have any
income since your son's illness arrived?
Ms. Mulhauser. No, I have not worked professionally since
my son's vaccine injury.
Dr. Weldon. How much of your time is consumed with caring
for your son, would you say, on a typical daily basis?
Ms. Mulhauser. It is 24 hours. I mean, he sleeps at night,
but even when he is in school, I am still responsible for
overseeing his therapies, scheduling his doctor's
appointments----
Dr. Weldon. Can you give me an idea----
Ms. Mulhauser [continuing]. Paperwork involved with the
annuities and the checks coming in, annual accountings,
financial accountings, petitions for maintenance to use the
fund that has been allocated for him. And I do a lot of
volunteer work related to his school and the rights of the
disabled, the rights of the deaf.
Dr. Weldon. And you have another child, is that right?
Ms. Mulhauser. Yes, I do.
Dr. Weldon. Is it safe to say that the vast majority of
your time since your son's illness has been devoted to
petitioning the Government for compensation, caring for him,
and that has essentially precluded you from working in your
field?
Ms. Mulhauser. Yes, that is true.
Dr. Weldon. I notice there is a gentleman with you. Is he
your husband, attorney?
Ms. Mulhauser. My husband.
Dr. Weldon. Your husband. Your husband has a job, I take
it?
Ms. Mulhauser. Yes.
Dr. Weldon. And I would imagine that the vast majority of
his free time when not working has been devoted to supporting
your son as well.
Ms. Mulhauser. Yes.
Dr. Weldon. And when you apply for compensation, you don't
request any compensation, and you are not eligible to get any
compensation based on your lost income and the time that you
have devoted to caring for your child. Is that correct?
Ms. Mulhauser. That is correct.
Dr. Weldon. OK.
Ms. Clements, I want to ask you the same line of
questioning. I see you brought your son with you today, and
there is a lady with you. I assume she is a relative of yours?
Ms. Clements. My sister.
Dr. Weldon. Your sister. I assume for you to go out
anywhere and do anything, you have to get either a family
member to sit in and help you or to have somebody paid come in
and help you? Is that correct?
Ms. Clements. I have someone in my family come in or take
him with me.
Dr. Weldon. OK. And as you have been trying to work through
the Vaccine Compensation Program, you are trying to get funds
just to take care of him. You are not petitioning for any loss
of your time, any pain and suffering on your part for this
case. Is that correct?
Ms. Clements. Correct. There is nothing that can--there is
no amount.
Dr. Weldon. Just one additional question I have for you.
You mentioned in your testimony that you were considering or
you are in the process of filing a claim against the
pharmaceutical company directly. Is that correct?
Ms. Clements. Correct.
Dr. Weldon. The purpose of the Vaccine Injury Program was
because the vaccine manufacturers said they were going to get
out of the business because of the huge number of claims that
were being filed against them. One of the concerns that I have
is that the program is so adversarial that individuals such as
yourself will start the process anew of filing claims against
the pharmaceutical companies, and then we can be right back to
square one that the system has truly failed us so badly that
the pharmaceutical companies are getting out of it again.
Would you say that it is a correct assessment that people
with situations such as yours have no choice and that they are
going to start filing claims against the pharmaceutical
companies?
Ms. Clements. Yes, I would say that is correct.
Dr. Weldon. Thank you, Mr. Chairman, or Madam Chairwoman. I
yield back.
Mrs. Mink [presiding]. Thank you.
I recognize the gentleman from Ohio, Mr. Kucinich.
Mr. Kucinich. Thank you very much, Mrs. Mink.
There are a few things that emerge when one views this very
important public policy issue. First of all, the role of
Congress. The question has been asked, and it should be put
before this committee, whether or not Congress has essentially
delegated away to HHS what is a legislative function.
With respect to the National Institutes of Health, it
appears to me that there absolutely is a need for more research
of the adverse vaccine reactions, because what we are dealing
with here is a system that provides for compensation for those
who have had an adverse vaccine reaction, but I think it is
incumbent upon us not to simply take it for granted that those
reactions will occur; that more emphasis needs to be put on
research to make sure that everything is being done to try to
limit the amount of reactions which are occurring.
The people who have come here today--and I have had a
chance to review the testimony--certainly have pointed stories,
and I think all Americans can sympathize with what happens when
a perfectly normal child is given a vaccine and ends up with a
catastrophic injury. And we have to care about that. We have to
be attuned to the kind of suffering that occurs. And, in a
sense, there is no amount of compensation that can genuinely
help a family and an individual who has gone through that kind
of trauma and will continue to go through it through their
entire life.
The thing that concerns me, Madam Chair, is that I
understand the existing law still permits the Department of
Justice to seek cost reimbursements from unsuccessful
petitioners who appeal their case to the U.S. Federal Court of
Appeals. Is that correct, Madam Chair and Mr. Mica?
See, that is one of the areas where this Congress, I think,
can intervene on behalf of those families who have suffered. It
just doesn't seem fair that one should have to go through a
route of trying to seek compensation or increased benefits and
cost reimbursements, and then if you happen to lose, to have
the Department of Justice come after you for the cost of an
appeal to the U.S. Federal Circuit Court of Appeals.
Again, I want to thank the chairman, Mr. Mica, for his
diligence on these issues, and the information that you have
already brought forward as a result of this committee's work
indicates that reforms are needed, and I am sure that with the
Chair working with Mrs. Mink and this committee, that we are
going to try to find some relief that will--it will never make
you whole again in terms of the damage that has been done to
your family and to your children, but it will let other
Americans know that Congress is listening and cares and wants
to do something.
So, thanks to all of you right here.
Thank you, Chairman.
Mr. Mica [presiding]. Thank you, Mr. Kucinich.
I recognize Mr. Cummings from Maryland.
Mr. Cummings. Thank you very much, Mr. Chairman.
I can only echo what Mr. Kucinich just said. I think that
so often when you think of something like a vaccine, looking at
something that is supposed to make life better and prevent
problems, and unfortunately in some instances we have a double-
edged sword.
I just have a few questions, Mr. Salamone. Is that how you
pronounce your name?
In your testimony, you advocate the creation of a specific
method or formula to calculate lost earnings. Yet some people
oppose such a formula, because it may diminish the awards to
successful petitioners. How would you respond to that concern?
Mr. Salamone. Well, you know, I have, I think, a very
personal reason for addressing that issue. In the case of my
son, he received zero, no compensation for future lost wages,
and I believe in this case the assumption was if he can walk--
which David does like a drunken sailor, but he gets around with
his brace--that he can, with educated parents, do as well in
this life as everyone else.
Well, within a year of his award, David started
intermittent tremors of his arms and hands. And as a result, he
now had to do much of his schoolwork on special equipment.
Well, our neurologist tells us this is directly related to his
polio, yet, again, this is something that was after the fact,
and therefore--by the way, if I can use this opportunity, the
original legislation provided that if indeed after a claim was
made something like this came up that was directly related to
the injury, that one had the option of going back to the
Government and saying, ``This is directly related. We have this
evidence,'' and the Government would work out an arrangement
where they could compensate, if you will, for the needs
relating to that additional injury.
Unfortunately, that was pulled back, and the Congress
actually removed that provision, and, as a result, in a case
like my son and others, you have this situation where, again,
they are not really being fully compensated for their injury.
Now, as far as the lost future wages, I believe that this
is obviously a complex issue, and the--my concern, candidly, is
the fact that people are totally eliminated from even
consideration for future lost wages. So, I think we, first,
have to establish the fact that there should not be a policy
with the Government that would allow a special master to have a
policy that says, ``You will not get future lost wages for your
child, because that child can walk or that child has educated
parents.'' Those are the things that concern me.
Mr. Cummings. There is a great deal of concern that if the
present program is changed, children whose conditions have not
been caused by the vaccines would receive compensation. And how
would you address that concern?
Mr. Salamone. I am sorry, sir. Repeat the question.
Mr. Cummings. In other words, there is a concern that if
the present program was changed, children whose conditions have
not--have not--been caused by the vaccines would receive
compensation.
Mr. Salamone. Well, I would first say to you I believe that
when it comes right down to it, the Government should err on
the part of the petitioner, if indeed it is an error. These are
very difficult cases. This is supposed to be a procedure that
is less adversarial, not non-adversarial, and certainly we
don't want to open the doors completely to cases that are not
directly related to vaccine injury. But I would say if we have
cases that even come close to consideration as vaccine-related,
that I would rather the Government with its $1.4 billion trust
err on the side of the petitioner.
Mr. Cummings. Well, I certainly would agree with that.
Unfortunately, we have many people here in the Congress who
probably wouldn't. When I look at all of this, having been a
trial lawyer for almost 20 years, to see the results of what
happens, for example, in a malpractice case and see how States
have limited the liability of doctors who may do the wrong
thing or may be negligent, it is interesting.
But when you go through this experience, when you have a
problem like this, a vaccine that actually had the opposite
effect that it was supposed to have, I think you get a chance
to see that--people get a chance to see that side of it. And I
would agree with you, and I hope that, as Mr. Kucinich said,
that we will be able to come up with some solutions that are
fair and that we will do justice to all of those who may have
been harmed.
And I want to thank all of our witnesses for being with us
today. Thank you very much.
Mr. Mica. Thank the gentleman from Maryland.
I would like to also thank all three of our panelists for
being with us and for the testimony you have provided the
subcommittee today. Hopefully, it can help us in doing a better
job in revising the law that was passed to compensate victims,
make the structure and system work that we put in place to
compensate for vaccine injuries.
So, we thank each of you, and we will excuse the witnesses
at this time.
I would like to call our second panelists. Panel two is Dr.
Marcel Kinsbourne, a medical expert with Tufts University; Dr.
Arnold Gale, a medical expert with Stanford University, and Mr.
Cliff Shoemaker, an attorney with Shoemaker & Horn.
As I indicated to our first panelists, this is an
investigation and oversight subcommittee of Congress. We will
swear in our witnesses. Also, if you have lengthy statements,
they will be made a part of the record.
Let me see, and is Dr. Gale going to testify too?
Can you raise your right hands?
[Witnesses sworn.]
Mr. Mica. Thank you. All of our witnesses answered in the
affirmative.
I would like to welcome each of you and thank you for your
participation today. And I think each of you have dealt with
this compensation fund and process, and we look forward to your
testimony at this time.
First, we will hear from Marcel Kinsbourne with Tufts
University.
You are recognized, sir.
STATEMENTS OF MARCEL KINSBOURNE, MEDICAL EXPERT, TUFTS
UNIVERSITY; ARNOLD GALE, MEDICAL EXPERT, STANFORD UNIVERSITY;
AND CLIFF SHOEMAKER, ATTORNEY, SHOEMAKER & HORN
Dr. Kinsbourne. Thank you, Mr. Chairman, members of the
committee.
My name is Marcel Kinsbourne. I am a pediatric neurologist.
I have held research grants from the NIH. I have served on
study groups of the NIH. I have been involved in the
Compensation Program since its inception in 1988; in fact,
before its inception, I was part of a workshop offered for
special masters in training for that purpose. So, I have an
overview of the program from its start.
I have also been involved in civil litigation, both for
plaintiff and defense, and so I am in a position to compare the
proceedings of the claims court Vaccine Compensation Act with
civil litigation in this country at this time.
Now, I might just say what everybody else agrees that I am
strongly in favor of public health policies with regard to
vaccination. I am addressing specifically the issues nominated
by the committee for discussion.
And the first of these, of course, is the question of the
adversarial nature of the proceedings as they now occur.
Actually, when the proceedings first began in the late
eighties, I didn't think they were that adversarial. I really
thought that they were somewhat consistent with the wording of
the act which was that they should proceed ``quickly, easily,
and with certainty and generosity.''
This changed, however, and the proceedings have become more
adversarial and continue to become more adversarial, and that
both involves the manner in which the cases are defended, the
petitioners are resisted, and the change in the rules that
offer a presumption of causation that have already been
mentioned by several speakers today.
These changes all go in one direction. I don't believe, as
I will explain, that the changes were made based on new
science. There isn't any relevant new science. The changes are
a matter of policy, in my opinion.
Now, in terms of the manner in which the proceedings are
conducted, it is increasingly the case in my experience that
the Department of Justice attorneys fight harder and more
stubbornly to resist findings of entitlement. They may use two
experts. They may change experts if the first expert's opinions
didn't serve the purpose. They may bring in three. A petitioner
can't usually manage to do that.
In one matter in which I have been involved, the Department
of Justice actually paid a group of independent investigators
to perform an original study, an expensive study, to overthrow
two claims for which entitlement had already been found. These
are the cases of Plavin and Hanlon v. HHS.
This kind of funding, this kind of effort isn't possibly
available to those plaintiff attorneys that still consent to
take these cases. And I might add that as has been said before,
absolutely there is no way of proceeding in these matters
without the help of an attorney; not just an attorney, an
attorney who is well versed in the procedures in the claims
court. It has become a highly specialized aspect of law.
So, not only is it the case that a special master is
pressured in many cases to deny entitlement, it is also the
case that when the special master nonetheless finds
entitlement, that the fight goes on, as you have heard,
increasingly at the damages hearings. Issues that had already
been settled in the previous hearing are revived yet again, and
then there is the nitpicking that has been described so well by
previous witnesses.
Now, not only does this make the process arduous and
exhausting, particularly for petitioners, it takes up time. I
heard it said at the last hearing, at which I also testified,
that the average time to settle a claim is 2 years. Well, I
don't know where that figure comes from. In my opinion, claims
that are contested and go through to entitlement findings take
longer. They have taken 4 years, 5 years. The last one that I
was involved in had been filed in 1991. As you have heard, the
more time passes, the less compensation is subsequently
offered.
Now, if the decision is one that is unwelcome to the
Department of Justice, the Department has the further resource
of resorting to a multi-stage appeals process, and appeals
against the decision of special masters have been increasingly
frequent in my experience.
Now, it is also my impression that as part of the more
stubborn contesting of these claims, there has been an
increasing effort to discredit medical experts who assist
petitioners by accusing them of bias against vaccination or in
favor of petitioners. In fact in the same last hearing I
mentioned, the Department of Justice attorney put into the
record as an impeachment exhibit the fact of my testimony to
this committee last time, and then she argued that the fact
that I testified to this committee showed that I was an
advocate, and should impeach my credibility as a medical
expert. I have the transcript with me.
The special masters----
Dr. Weldon. Mr. Chairman, I ask that that transcript be
included in the record.
Mr. Mica. Without objection, so ordered.
[The information referred to follows:]
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Dr. Kinsbourne. In my opinion, the special masters make
every reasonable effort to adhere to the principle of a non-
adversarial and friendly and expeditious process. They used
relaxed rules of procedure. They are invariably courteous and
compassionate to the plaintiffs. They try to move the case
along, but this gets increasingly hard because of the
opposition that is encountered at every step of the way.
I think that in summary, the quality of the proceedings has
approximated to the kind of adversarial argumentation and
maneuvering that is typical of civil litigation, and the
question is, is that what Congress wants?
The second topic nominated by the committee was the matter
of criteria for entitlement for compensation. In other words,
what are the criteria by which a claim can be automatically
accepted as indicating that the damage complained of was caused
by vaccine? Now, I would like to explain why this is so
important.
If it were the case that we had special tests for vaccine
injury, if it were the case that the outcomes of vaccine injury
were typical and that you could look at the chart years later
and say, ``Ah, this must have been a vaccine case,'' then there
wouldn't be such a problem. But in child neurology this is the
exception rather than the rule. The reason is that there are a
legion of causes of damage to children's brains, but the way
the children's brains react to these damages is quite limited,
and the most common outcomes are cerebral palsy, mental
retardation, and seizure disorders. And it is usually the case
that you cannot tell from the cerebral palsy, from the
seizures, or from the mental retardation what the cause was.
So, in the case of vaccine injury it is like that. If one
had to actually prove that the vaccine definitely caused the
outcome, that would be hard and sometimes not a possible job to
do, as is the case also with other causes in child neurology.
One reason why this proof is so difficult is that research
is lacking. Now, the research that is lacking is research that
could, in fact, often well have been done by now. In fact, the
initial act instructed the Secretary to commission the
Institute of Medicine to prepare reports on the status of the
science of vaccine injury causation, and they did so in two
reports I think in 1991 and 1994.
In the report in 1994, they made a point of a fact that
they had encountered in their efforts, from chapter 11, ``The
lack of adequate data regarding many of the adverse events of
the study was of major concern to this committee. Obvious needs
for research and surveillance were identified.'' This opinion
of the committee of the Institute of Medicine was published in
1994. I am not aware that anything was done about it.
Now, in fact, the rule changes that have been referred to,
implemented in 1995 and 1996, were changes that, as everybody
knows, made it harder for petitioners to prevail in their
actions. These changes were not based on new science. There is
no new science. They were not based on the Institute of
Medicine recommendation. Actually, they ran counter to those
recommendations.
Here is a specific about that. In the case of DPT
vaccination, which is by far the commonest vaccination
complained of, there really is only one epidemiological study
that has been recognized as being definitive and reliable, and
I quote from a publication of the Institute of Medicine. The
study is called the NCES, National Childhood Encephalopathy
study, which was done in Britain. The committee says, ``The
NCES is the only systematic study of long-term dysfunction
after DPT,'' and the committee endorsed that study, and the
following statement is to be found in the same document: ``The
committee concludes that the balance of evidence is consistent
with a causal relation between DPT and the forms of chronic
nervous dysfunction described in the NCES in those children who
experienced serious, acute, neurological illness within 7 days
after receiving DPT vaccine.''
So, what are these acute, neurological events? They
subdivide into encephalopathy and seizures. The NCES studied
serious seizures lasting more than half an hour or complicated
seizures. Well, what happened after that? Seizures were removed
from the table of entitlement after the IOM accepted the study
which incriminated them in relation to DPT.
Encephalopathy. How was encephalopathy defined by the NCES,
which was endorsed by the IOM? I would give a list, if I may,
of the characteristics that were mentioned in the NCES
document: altered state of consciousness, confusion,
irritability, changes in behavior, screaming attacks, neck
stiffness, convulsions, visual, auditory, and speech
disturbances, motor and sensory defects. This is the list the
NCES gave, and it is a list that is not inconsistent with
neurological practice.
What is left after the change? One thing: lowered level of
consciousness after 24 hours. If you don't have that, never
mind you have all these other symptoms, you are not on the
table, and God forbid you die before the 24 hours are up,
because then, certainly, you haven't met the criteria.
So, I wish to present to the committee that the presumption
of causation has been restricted to the point that it is
tantamount to causation-in-fact. It is tantamount to going and
proving the case in court every time over again. So, we have
instead this lengthy process, this arduous process which might
as well be conducted against the manufacturers as in the court
of claims.
And, now, the Secretary has introduced proposals for
legislative changes. In section three of the proposals, there
is a suggestion which would make it easier for the Government
to overthrow even table injuries. Now, when petitioners have to
prove causation-in-fact because their injuries aren't on the
table, they have to prove that the pertussis vaccine or other
vaccine really caused the problem.
But the Secretary would like to change the burden on the
respondent to overthrow a table injury by not having them
actually prove the specific disease but merely argue, ``Oh,
there was a genetic cause. There was a metabolic cause.'' That
is in section three. That section would make it even harder to
recover under the terms of the act.
Now, with respect to the third point, I have only a brief
comment to make. As has been mentioned several times, there is
a large amount of money in the trust fund. It was contributed
not by manufacturers, not by the Government, but by citizens
when they purchased vaccines. The purpose was to compensate
people who are injured by vaccines. I believe the money should
continue to be used for that purpose.
Thank you, sir.
[The prepared statement of Mr. Kinsbourne follows:]
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Mr. Mica. Thank you for your testimony.
We will now hear from Dr. Arnold Gale with Stanford
University.
You are recognized, sir.
Dr. Gale. Thank you, Mr. Chairman, the ranking minority
member, Mrs. Mink, and ladies and gentleman of the committee.
Thank you for the privilege of testifying today about the
Vaccine Injury Compensation Program. I am a child neurologist
and a member of the faculty of the Stanford University School
of Medicine. And for the past decade, I have participated in
the program by lending my expertise to the review of the
medical records of petitioners filing claims for compensation.
At the same time, I have acquired a perspective of the process
itself and of the deeper issue of vaccine-related injury, which
I should like to share with you this morning. Although a wide
variety of vaccines are covered by the program, and while my
remarks are pertinent to all of them, I will focus primarily
upon the pertussis vaccine, which has given rise to the vast
majority of claims.
My role as a medical reviewer for the program is little
different than that which I perform in my usual capacity as a
clinician. Keeping in mind the criteria that are set forth in
the vaccine injury table, I review the medical records and the
supporting documents of each claim, seeking to answer these
questions: Does a condition described on the table exist? If
so, has it occurred within the prescribed timeframe? And if so,
can a factor unrelated to the vaccine be identified as the
probable cause of the condition?
If a condition described in the table occurs within the
prescribed timeframe, and if no factor unrelated to the vaccine
can be identified as the probable cause of the injury, then the
claim is compensable under the National Childhood Vaccine
Injury Act. I file a report with the program to that effect,
and the claim typically proceeds to the damages phase of the
process.
Alternatively, if no condition described in the table can
be identified, or if a condition has its onset beyond the
prescribed timeframe, or if a factor unrelated to the vaccine
can be identified as the probable cause of the condition, then
the claim is not compensable under the act. I file a report to
that effect, and the entitlement phase continues, typically
proceeding to an adjudicative hearing before a special master.
The process is similar in cases in which a child may have
suffered a significant aggravation of a pre-existing condition
following immunization.
Under the act, a table injury without an identifiable
factor unrelated to the vaccine is presumed to have been caused
by the vaccine, and proof of causation is not required. Only
when injuries occur beyond the timeframe of the table does the
petitioner have the burden of the proof of causation. The
fairness of the program rests heavily, I believe, upon this
principle.
The act provides for periodic revision of the table based
upon experience and the evolving understanding of the science
and the medicine governing the table. With respect to the
pertussis vaccine, perhaps the most significant of these
revisions occurred in March 1995, when ``residual seizure
disorder,'' was eliminated as a distinct condition, and the
definition of ``encephalopathy'' was changed. The former was
undertaken only after careful consideration of the cumulative
experience with seizures following immunization.
Most seizures closely following immunization are febrile
seizures, which are typically brief, self-limited events
affecting genetically predisposed infants and children. They
are benign and are not associated with untoward outcomes.
Most of the remaining seizures may be triggered by fever in
children who have occult epilepsy--that is, an already existing
epilepsy--but there is no evidence that the epilepsy itself is
caused by the vaccine, except when accompanied by signs or
symptoms of an acute encephalopathy. Relatively few cases have
been affected by this change in the table.
In contrast to more than 3,600 DTP-related claims
adjudicated under the initial table, fewer than 300 total
claims have been filed since the change in 1995. The definition
of ``encephalopathy'' incorporated into the initial table was
vague and confusing to my way of thinking and to that of my
colleagues, and it disregarded the differences in the signs and
symptoms that are observed in infants and older children.
Because I had a role in framing the language of the new
definition in 1995, I can attest that the change was motivated
solely by a desire to clarify. Only a small fraction of cases
filed since that change has been affected.
If my description of the mechanics of the program, and of
its underlying table, is itself a little mechanical and a bit
dry, the same cannot be said of the program's hearing process.
Its adversarial nature is ensured by the participation of
lawyers and the special master. What should be a quiet, civil,
deliberative discussion of facts and medicine too frequently
degenerates into a contentious, vituperative, decibel-
escalating exchange. Ad hominem attacks on physicians by all
attorneys are common.
Most disturbing, from my perspective, has been the
injection of pseudo-science provided by self-proclaimed
vaccine-ologists. With accumulated experience, however, the
special masters appear better able to readily identify such
witnesses, crediting their testimony with the weight that it
deserves.
Each participant in the program--parents, special masters,
attorneys, physicians, and others with stakes in the process--
possesses a unique perspective, and it is that perspective
which creates perception. Perception is a powerful thing. In
1977, the British Broadcasting Co. televised a documentary
warning parents of the potential dangers of the pertussis
vaccine. During the ensuing year, the rate of immunization
among infants in Great Britain, a nation with accessible, free
health care, plummeted approximately 45 percent. During that
same period, in a population roughly a quarter that of the
United States, the number of deaths from pertussis, or whooping
cough, was quadruple our own. All too quickly, the perception
of risk, which motivated so many parents to withhold
immunizations, was replaced by grief.
The parents who petition the program have their own
perspectives and perceptions, and they have my empathy and my
sympathy for the loss of the children who would have been
adults. Often their children have serious chronic neurologic
disabilities, and they grieve for lost hopes and dreams. Among
their needs is the need to know why. Compensation from the
program, then, provides more than the financial resources for
future care and the accompanying peace of mind. It vindicates
the strongly held belief that the vaccine is at fault, despite
the fact that there is no method available to determine whether
the vaccine did, in fact, injure their child.
The special masters are dedicated to the principles that
guide the program, the first of which is compassion.
Uncompensated claims are not attributable to their
indifference, but rather to the relatively small number of
cases that satisfy the minimal requirements of the table. Never
is the problem of perception as poignant as in the instance of
the sudden, unexplained death of an infant following
immunization.
In approximately half of such cases, the medical and
pathological records are consistent with Sudden Infant Death
Syndrome [SIDS], a condition not associated with pertussis
immunization, according to the medical literature and the
report of the Institute of Medicine. Still, it is unlikely that
anything will dissuade a grieving parent that the close
temporal relationship between immunization and an infant's
death is coincidental.
In nearly 25 years as a clinician, I have witnessed a few
rare cases of infants and children whose acute neurologic
disorders began immediately following immunization, and for
which no reasonable alternative could be identified. Like most
of my colleagues, I think that such events occur, may be
vaccine-related, but that they are rare.
With respect to the pertussis vaccine, there is no method
available today that permits causation in any individual case
to be established. This opinion is widely held and well-
supported by the current medical literature. My own decade-long
experience with the program has taught me that literally
hundreds, if not thousands, of youngsters whose parents believe
that they have been injured by vaccines, have, in fact,
alternative diagnoses that account for their neurological
disabilities. The rarity of vaccine-related injuries makes
epidemiological studies difficult to design and execute, and
such studies could not establish causation in an individual
case nor prove that such injuries never occur.
A half-century after widespread immunization began, our
knowledge of such injuries is sparse. What we do know is that
countless lives have been saved and serious illness and
disability prevented by immunizing against infectious diseases
that were once the scourges of humanity. And, those vaccines
have never been safer than they are today.
Thank you again for the privilege of testifying before you
today on this critical matter.
[The prepared statement of Dr. Gale follows:]
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Mr. Mica. Thank you, and we will hear from our third
witness, Mr. Cliff Shoemaker. He is an attorney with Shoemaker
& Horn.
Welcome, and you are recognized, sir.
Mr. Shoemaker. Thank you, Mr. Chairman. I am flattered to
be included on a panel with two esteemed doctors. I probably
would be more appropriately placed on the panel with John Euler
who is probably my counterpart in this program.
Mr. Chairman and members of the subcommittee, I am very
pleased to be with you here today to talk to you about a
subject that is very near and dear to me. Before I begin, let
me begin by saying that I would like to place my father's name,
Ralph Shoemaker, in the Congressional Record. My father died on
September 11 as I was preparing my testimony for this hearing,
and my remembrances of him were constantly with me as I
prepared this testimony.
I often tell people that I represent saints--the parents of
children who have been profoundly injured as the result of
vaccinations. But I want you to understand that I am not--and I
repeat the word ``not''--against vaccinations. It is important
that you understand where I am coming from in this regard. You
see, my parents are also saints; not because they put up with
me, but because they raised a handicapped child and helped her
to become a fulfilled, beautiful person.
The year that I was born, one of my sisters, who was then
9, contracted polio. She has lived her life in a wheelchair,
because vaccines to protect her against that dread disease had
not yet been developed. So now, as Paul Harvey would say, you
know the rest of my story and one of the reasons why I am so
committed to the development of safe and effective vaccines
designed to protect us against serious diseases.
And I might add as a sidelight here, Congressman Burton had
an exchange with Mr. Salamone, and it brings up a perfect
example of what I am talking about, because I am one of the
people who has said we cannot stop giving polio vaccines until
we have vaccinated our population for at least 10 years with
kill virus vaccine. The reason for that is that we do have
cases of people who have contracted polio from live polio
vaccine. We know that they can shed that virus for at least 8
years, so there is a pool of polio virus there, and you cannot
stop giving polio vaccine, at least not the kill vaccine, until
we are absolutely sure that this disease has been eradicated.
So, if there is any doubt about my view on vaccines, that is
it.
In a very real sense, I am here today testifying on behalf
of the United States--excuse me, sir.
Mr. Mica. If I may submit my unanimous consent your request
for also the inclusion of your father's mention, Ralph
Shoemaker, into the record and also your entire statement.
Without objection, so ordered.
If you would care to go ahead and summarize. Thank you.
Mr. Shoemaker. Thank you, sir.
In a very real sense, sir, I am here today testifying on
behalf of the U.S. Government; that is, that part of the
Government which is ``of the people, by the people and for the
people.'' Abraham Lincoln once said, ``It is as much the duty
of Government to render prompt justice against itself, in favor
of its citizens, as it is to administer the same, between
private individuals.''
I have been involved in vaccine litigation for over 20
years. Prior to the enactment of the Compensation Act in 1986,
the families of children, as Congressman Waxman explained, were
forced to hire lawyers and file lawsuits against the vaccine
manufacturers and vaccine administrators. These suits were
expensive and time-consuming, and the results were quite
variable.
At a ``Symposium on Public Concerns of Immunization'' held
at Georgetown University in 1978, Dr. Leroy Walters made the
following statement, which I think is very appropriate for our
discussion today. He said,
Consider the following metaphor drawn from military
service: Mass immunization programs are a significant element
in the war on infectious disease. In mandatory immunization
programs, a system of conscription is employed to recruit
soldiers for this anti-disease campaign. As it happens, most of
the recruits in the war on infectious diseases are children. In
most cases, participation in the war on infectious diseases is
beneficial to the young soldiers themselves. However, at least
part of the rationale for conscription is that the pediatric
warriors will protect other children and the population as a
whole against the onslaughts of infectious disease. As in all
wars, some soldiers are injured. The number of child-soldiers
and their contacts who are actually wounded in this war is
small, almost infinitesimal. Yet service-connected disabilities
do occur. At present, the draftees who are injured in the war
on infectious disease are in effect told by the conscripting
authorities, ``Thank you for your contribution to the war
effort, and best of success in coping with your disabilities.''
If you don't mind, I feel very funny just reading into the
record something that I have already written and everyone can
read for themselves. I would like to respond to some of the
things that I have heard here today. I feel like I am ready to
explode with so much information and so much that needs to be
talked about.
Congressman Waxman indicated this program was created
because plaintiffs only had this alternative to going into
court, and that is true. But as Congressman Burton pointed out,
this program was created because there was a national
emergency, and that national emergency was that the vaccine
manufacturers were threatening to stop the production of
vaccines. This was an emergency, and Congress dealt with that
emergency in a brilliant fashion.
Congress brought together people from all different walks
of life. They brought in the manufacturers; they brought in
people from the Department of Justice, from HSS; they brought
in victims; they brought in groups that represented victims.
They took all these people together, and they forged a
political compromise. And I think it is important to understand
that that was a political compromise, not a scientific
decision, not a medical decision, it was a political
compromise. The table of injuries that everybody has talked
about today was a political compromise.
Dr. Kinsbourne is right--there was no new evidence that
justified changing that table when the Secretary changed the
table, and I hope you will read what I have said about that.
The table is changed now so we have a situation where the only
encephalopathy is one where you have reduced level of
consciousness for at least 24 hours. Now, maybe Dr. Gale can
explain to me how a vaccine that is capable of producing that
kind of an injury cannot produce an injury that is less severe?
If it can produce a severe injury, it can produce a less severe
one.
Congressman Burton asked questions about the hepatitis B
vaccine. How do you make a study--when you give a baby a
hepatitis B vaccine in the hospital before they leave, how are
you going to conduct the study that Dr. Gale asked about, a
study of epidemiology? How are you going to design and
implement a study, because you have nothing to compare that
baby with? At 2 and 4 and 6 months, it is hard enough to know
what the baby was like and to show before and after--that is
tough enough. But you give it to a baby and the baby has an
injury from the vaccine, how can you prove it? How do I prove
it as a lawyer? That is the perfect way to disguise an injury
from a vaccine. Give it to a baby, and then you can blame it on
genetics or structural abnormalities, and that is what the
Secretary is asking you to do, to not only make changes to this
program but make it more difficult to collect on these cases.
If you agree with their language on genetic abnormalities and
structural lesions, I can guarantee you that there won't be
anybody on this case.
I just returned from Florida where I visited and met with
lawyers who are prepared to work on hepatitis B vaccine claims.
We filed over 130 such claims, and I can tell Congressman
Burton that the problem we have in this program is that our
meeting was not to discuss--well, it was to discuss how we are
going to prove causation in these cases--but our meeting was to
discuss what we are going to do when we are forced out of this
program if it is not changed and how we are going to mount
civil litigation in these cases. That is the discussion we were
holding.
You are absolutely correct in saying if this program is not
fixed, I can guarantee you that the hawks that are sitting on
the sidelines and calling me crazy for staying involved in this
program are going to carry the day, and we are going to be back
in court suing manufacturers, suing doctors, doctors who didn't
recognize that the first shot caused problems, the second shot
caused problems, and they went ahead and gave the third shot.
One of the things we see of hepatitis B vaccine cases is we
see people who received a series of vaccines and had repeated
injuries after each vaccine to that. We have got to develop
methods of showing doctors and telling doctors that if a child
has a reaction to one vaccine, you don't give him anymore. Stop
this dogma of giving it to a child.
We are working with doctors now who are trying to determine
if there are genetic abnormalities or genetic genomes or
genotypes that can help us to identify children who are high
risk of developing reactions to vaccine. That is research that
we are doing--plaintiffs' lawyers, the scourge of the Earth. It
is not being done in the places where it should be done. We
need research today, but we also need a program, and I
encourage you when you think of that military analogy, give us
the burden of proof that you use for veterans' claims. Give us
a burden of proof where the benefit of the doubt truly goes to
the petitioner. Take away this idea that this is a waiver of
sovereign immunity and that everything should be narrowly
construed against the claimants. That is not the case. This is
a compensation program; it is remedial. The benefit of the
doubt should be in the favor of the claimants in these cases,
and if this program doesn't start working, something is going
to happen.
I can't prove causation in a case the way I used to prove
in contingency litigation. It was not uncommon for me to spend
$50,000 on a case to prove causation--hiring experts,
performing epidemiological studies, performing biological
testing programs. I can't afford to do that in this program.
Today, when I am finally compensated with the meager
compensation that I get from this program and the expense
reimbursement, I am paying yesterday's bills.
That is why none of my compatriots, none of the litigation
lawyers in this country are willing to stay involved in this
program. You heard from one of the claimants that her firm is
no longer taking any vaccine cases. It is a respectable, well-
respected plaintiffs' firm. Those firms will not get involved
in these cases, because they can't get paid on time; they can't
get their expenses reimbursed until the end of the case; they
cannot afford to handle these cases.
The war chest that I once carried when I was in contingency
litigation is gone. I can no longer afford to do the things
that I need to do. I am embarrassed by the limited amount of
things that I can do to prosecute these cases. And I would say
to Congressman Burton, sure I will be happy to represent your
grandchildren, but can you come up with $40,000 or $50,000 to
help me do the studies necessary to prove causation in these
cases? Because the Government won't do it, and there is a
reason why they won't. They feel like if they show or
demonstrate that there is a problem with a vaccine, then people
are going to be afraid, and people are going to not get the
vaccines.
Let me just say--and this is in the conclusion of my
presentation--anybody who points to this program and points to
the children who are compensated and uses that as evidence that
vaccines are dangerous ought to be ashamed of themselves. And
anybody who points to this program on the other side of the
case and says that the fact that such a small percentage are
compensated shows these vaccines are safe and people are just
full of hot air, they ought to also be ashamed themselves.
That is not the purpose of this program. It is not to try
vaccines and determine whether they are safe. The purpose of
this program is to compensate people in a fair and generous and
simple way. If it is going to be highly adversarial, if we are
going to have three and four experts hired in every case to
testify against us, then give me the resources, give me the
money to fight this battle like I would fight it in civil
court.
But I can't fight these battles the way this program is
structured now. And that is why attorneys like myself are
planning for the future, and the planning for the future is if
this program isn't fixed, then it will not be the model for
tort reform that we all want. It will be a perfect example of
how not to reform the tort system.
Thank you.
[The prepared statement of Mr. Shoemaker follows:]
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Dr. Weldon [presiding]. Thank you, Mr. Shoemaker.
We will now proceed with the questioning phase. And the
ranking member and the chairman had to step out, so I am going
to continue until they return.
Dr. Kinsbourne, I would like to begin with you. I have to
apologize, I was paged out of the room by a phone call, but I
was told that in your testimony you mentioned that after you
appeared before the committee the last time, you were
testifying in another case, the objectivity of your testimony
was impugned by the Government attorney because of your
willingness to testify before the committee. Is that correct?
Dr. Kinsbourne. That is exactly what happened.
Dr. Weldon. And what was the name of the attorney who made
that claim?
Dr. Kinsbourne. Her name is Hewitt.
Dr. Weldon. And what is her position? Is she Department of
Justice?
Dr. Kinsbourne. Department of Justice, yes.
Dr. Weldon. Could we get a copy of that exchange between
you and her for the record, and I ask unanimous consent that it
be included in the record.
What was the nature of her argument? Could you just go over
that?
Let me just explain, the reason I am bringing this up is I
am very disturbed by this. Because if this means that every
time we petition an attorney to provide us with testimony that
the Government attorneys who are trying to protect this huge
trust fund for some reason, I don't understand--it is growing,
and yet they keep trying to protect it--then we are going to
have a hard time getting people to objectively tell us what the
problems are in this system. And I find that testimony you
provided extremely disturbing. You are free to proceed. I am
curious to know what was the nature of the exchange?
Dr. Kinsbourne. As I said, I do have the transcript, and I
will make it available.
Dr. Weldon. Just summarize it.
Dr. Kinsbourne. What happened was that in her cross
examination of me, she produced my written testimony to the
previous committee meeting as an exhibit; had me identify it;
had me read passages out of it into the record; did not, in
fact, challenge anything I said; asked me no questions about
what I said, but established that this was my document, this
was my testimony.
Dr. Weldon. As I understand it, though, reviewing your
personal background, you have a pretty impressive record of
working on both sides of this issue, correct?
Dr. Kinsbourne. I have an impressive record--thank you,
sir--of working of both sides of issues; of plaintiff and
defense. However, in the claims court, it is not customary for
the Department of Justice to include experts who testified on
the other side. So, I have not, in fact, had the opportunity of
testifying for respondent, although I have expressed my
willingness to do so in appropriate cases.
Now, when it came to closing argument, Ms. Hewitt said to
the judge ``The fact that Dr. Kinsbourne did testify to a
congressional committee and had criticisms of the process shows
that he is to some extent an advocate,'' and she compared me
unfavorably, in terms of my credibility as a medical expert,
with her medical expert who she felt was not an advocate.
Dr. Weldon. One other question I have for you. You provided
in your testimony some information on a report from the
Institute of Medicine, actually, a fairly old report from the
Institute of Medicine--I think it was 1991 or 1992--where they
recommended a series of studies that needed to be done to get
at some of these issues of low incidence of very serious side
effects regarding vaccines. I would like to ask that we get a
copy of that from you and get that included in the record. I
ask unanimous consent for that.
Mr. Mica [presiding]. Without objection, so ordered.
Dr. Weldon. As I understand it, none of those studies have
been done. Is that correct?
Dr. Kinsbourne. To my knowledge. The point is not only that
when they asked whether particular vaccines do or do not in
principle cause certain outcomes, they have no studies to refer
to, and they were stuck with this and went out of their way to
make that point, and I will provide the information.
Since that time, this problem has become more serious as
new vaccines are being introduced, which almost without
exception would have been classified by them in this way had
they been available at the time. In other words, vaccines about
which one really simply couldn't say one way or the other
whether the relationship existed, not because studies conflict,
because studies don't exist; have not in fact been done.
The hepatitis B issue that Mr. Shoemaker mentioned is a
major problem in this case. Hepatitis B has been put on the
table for a very rare, almost unknown complication--
anaphylaxis. But the impression that many people have that
hepatitis B can cause liver damage, it can cause autoimmune
disorders, has not been addressed by systematic scientific
study. So, if one is asked, as one currently is, to proceed on
a causation-in-fact basis and one has to show biological
plausibility, one has to show that actually, in fact, there is
evidence that the vaccine did that based on available
scientific evidence, there is no such evidence, and the
petitioner is out of luck.
Mr. Shoemaker. May I add to what Dr. Kinsbourne just said?
Dr. Weldon. Sure.
Mr. Shoemaker. There are studies and then there are
studies. To use the hepatitis B example, we are seeing a lot of
cases of post-vaccinal encephalomyelitis--that is injury to the
nervous system, the brain, the spinal cord. So, what does the
study do? What is the study that is mounted to look at that? It
is a study to see if there is an increased incidence of
multiple sclerosis in hepatitis B vaccine--people who receive
the vaccine.
Now, multiple sclerosis is this great big category of
injuries. All it means is multiple lesions in time and space.
Post-vaccinal encephalomyelitis is a very little piece, and
actually if it is post-vaccinal encephalomyelitis, it shouldn't
even be included in multiple sclerosis, because it has another
cause.
So, you look at this great, big universe and study it to
try to disprove a relationship between vaccine and post-
vaccinal encephalomyelitis? If that is the study that is being
done, then I say forget the study, save your money. Don't spend
your money on a multiple sclerosis study, because there are so
many causes of multiple sclerosis that if you try and look and
see if the total universe of multiple sclerosis because of
hepatitis B vaccine, you won't find it. I can tell you that
before you spend the first dollar, and that is not the type of
study that needs to be done.
So, there are studies, and then there are studies, and you
have to do the right kind of study. What we are seeing in those
cases, for instance, is people that have a reaction to the
first vaccine in the series, they start getting better, having
some recovery. They get the second vaccine in the series, and
they have a much more immediate and more pronounced response to
the vaccine.
It is what the Government and other doctors refer to as
positive rechallenge. In other words, once could be a
coincidence, but twice, now you see what is happening. You have
heard this from one of the victims who testified today where it
wasn't until after the third vaccination that they finally
said, ``OK, we have got to stop these vaccines.''
Dr. Weldon. I would like to ask all three of you to comment
on this one question or concern I have. I am a physician, and
this is my first political job, and the devil is always in the
details when we try to address these problems. And now we have
an act, the Vaccine Compensation Program; it had very good
intentions; it has gone astray, and, frankly, I think the
attorneys have led us astray. Not to impugn you, Mr. Shoemaker
or your profession, but it is just by nature, as Mr. Gale said,
you put two attorneys in the room and it becomes who is going
to win. And one side has more funds in their pocket to fight
their battle. I don't think you can get the attorneys out of
the room, frankly. I don't see how you can do that, and that is
one question I have--could you do this without attorneys? I
don't know if it is possible.
But one of the questions I have is should we have language
in the law that requires that the plaintiffs' attorneys get
compensated better, because this system is terrible the way it
is described where there are virtually no attorneys willing to
practice this type of law anymore? I believe that is going to
need to be addressed.
And, No. 2, do we need to mandate that a certain amount of
the money gets dispersed each year? Because if you are going to
have all these Department of Justice attorneys going to work
each day, and their definition of winning is that no money is
given out, and they have got the deeper pockets to defend their
position, then the ultimate solution may be to mandate that a
certain amount of the money each year be given out and that it
not become a case of who wins and who loses.
I am just looking toward, ultimately, the day when we begin
to draft language that will attempt to try to address the
problems with this program, because I think we are going to
have to do that. It is critically important that we protect the
Vaccination Program.
Mr. Shoemaker. If I may respond to that. I hope you will
read what I have written about interim fees and costs, because
the Government experts, when they testify in these cases, they
submit bills; they are paid within 30 days. I could have
brought a stack of bills here today from doctors that I can't
afford to pay right now.
It is kind of hard for me as a plaintiffs' lawyer to go out
and beg some doctor to testify for me in a case when I can't
pay them up front, and I tell them, ``You may have to wait
years to be compensated at the end of this program.'' I mean,
that is me asking them to testify versus somebody calling them
from Health and Human Services and asking them to testify. That
is not quite an even playing field, and I hope you will read
that section about interim fees and costs.
It is important that we be allowed to petition for costs. I
just filed 130 hepatitis B claims. The filing fees alone were
$16,000. If it costs me $500 a case to obtain medical records,
multiply that by 130, you are looking at $30,000 or $40,000 to
collect records. Now, if I can get an expert at $1,000 apiece
to review those claims, that is $130,000. I am paying
yesterday's bills with the fees that I am getting today on
cases that have been going on for years.
I have remortgaged my house twice. I have taken my kids out
of private school and put them in public school. I have gotten
rid of the boat. I am no longer living the life of a contingent
fee lawyer, and my friends think I am an idiot to stay involved
in this program, and maybe I am, but I am dedicated to the
program. But if we are going to have to fight causation battles
in these cases, give us the resources to do it.
And I reject the Government's proposal to give us interim
costs after an entitlement hearing. That is a token offer, and
I reject it. If you are going to give us interim costs and
fees, give it to us at least several times during the course of
a proceeding so we can finance the cases and pay for them.
Dr. Weldon. Dr. Gale, did you have anything you wanted to
add to that?
Dr. Gale. Yes, if I might. There are ways to streamline the
process and to make the process less cumbersome, to have the
process take much less time to compensate people. It could be
an administrative process. That isn't what it is now. Now, it
clearly is a litigative process. I don't have experience in
civil court, so I don't have a basis for comparison, but I am
told that it is a milder experience, but it is still a
litigative process.
There would be no need to review records if there weren't a
table to compare medical records against. And there would be no
reason to have medical opinions if we didn't have a table. So,
clearly, the table, which is the linchpin of the program means
that there will be a need for physicians on both sides to
review records and come up with professional opinions about
what likely happened to this youngster, when did it happen, and
whether or not it was caused by something other than the
vaccine.
That could be eliminated. People could fill out a simple,
plain English form, explain what happened to their youngster,
submit a form, and be compensated. That could happen. I can't
do that, but the Congress could do that, if that is what it
envisions for the program. If it maintains the table, however,
then there will be physicians involved. It does not, however,
have to be an adversarial process if there is a bank of
physicians reviewing records with the broadest possible
definition of the injuries.
There are three things that can be done to the table,
because the table essentially mandates three things. It
describes the injuries that are compensable. It describes the
timeframe during which the onset of the injury must occur, and
then it describes, I suppose you could call it, ``an out,'' and
that is, if there is a factor readily identifiable separate
from the vaccine that could have caused that injury in that
timeframe, then that becomes a non-compensable case.
For example, you could do away with the provision for
factors unrelated; that is, you wouldn't bother to look for a
factor unrelated; you wouldn't care. Then a prescribed injury
occurring within a certain timeframe, no matter what the
child's medical record or history suggested, would be
compensable.
Second, you could expand the timeframe. For example, in
pertussis vaccines for encephalopathy it is currently 3 days.
You could make it 7; you could make it 14; you could make it a
month or more. That clearly would expand, not only
scientifically, the probability that you would not have
permitted any potentially vaccine-caused injuries to fall
through the cracks, but necessarily, using the principle, I
suppose, of unanticipated consequence, you would include an
awful lot of youngsters with neurologic diseases that almost
certainly couldn't have been caused by the vaccine. But that is
a decision you could make; you could expand the time window.
And last but not least, you could change, again, the
definitions in the table, if you keep a table, and make them as
broad as possible.
Mr. Shoemaker. In that regard, making them broad, if you
look at the IOM report that you referred to, there are many
conditions that describe, with reference to various vaccines,
where the report will say specifically this condition--like,
let us take brachial neuritis--this condition is biologically
plausible. In other words, it is plausible that the vaccine
caused it and that there have been case reports in the
literature reporting this, but there have been no controlled
epidemiological studies performed, and therefore their
conclusion is that there is not enough evidence to either
accept or reject the fact that this was caused by the vaccine.
If those were put in the table, if you included all those
things where it is biological plausible and where there are
case reports and there haven't been epidemiological studies,
you would include a lot more cases within the table. I like the
idea of eliminating the alternate causes to be able to
streamline the table. Sure, you would overcompensate more than
you are now, but so what? Otherwise, you end up with people on
Medicaid; you end up with people with other programs. I mean,
let us open this program up and make it compensate, make it do
some good.
Dr. Weldon. Did you have anything you wanted to add to
that, Dr. Kinsbourne?
Dr. Kinsbourne. Yes, sir. I think that Dr. Gale's
suggestions are very humane, and I could certainly not take
issue with them. I do think that the medicine, as I have
explained, is particularly technical here, and it is not always
obvious to a layperson what is or what is not a vaccine injury,
or even what could be or what could not be a vaccine injury. I
have reviewed many files sent to me, and many times I am unable
to support the claims, because I can tell that this really
wasn't the vaccine.
So, I think regardless of how one sets one's criteria, we
still need some legal assistance and some medical consultation,
but it could be an awful lot less than currently happens. It
could absolutely streamline in the ways that my colleagues have
suggested.
Mr. Shoemaker. You still need to leave open the possibility
of people that don't fit a table, even an expanded table. You
need to leave open the possibility of being able to prove
causation-in-fact in those cases, and I would encourage you in
those cases to adopt the standard of proof that is used in
veterans' claims.
If you look at what I have written here on veterans'
claims--and if I can point to that page very quickly since I
didn't follow my script here today--it is at the bottom of page
8 and on page 9. I have put in the specific language that is
used in 38 U.S.C. section 5107 for veterans' claims. And it has
the language in it where it says specifically ``The benefit of
the doubt in resolving each such issue shall be given to the
claimant.'' It is taking it out of the civil context. If we are
not going to be in civil courts and if we are not going to be
litigious, if we are going to make this a program that is non-
litigious, then let us use a standard like this.
I think the military analogy that I referred to at the
beginning about our pediatric warriors, it makes sense to use
the same standard of proof that we use in veterans' claims. So,
I would encourage you to look at that on page 9, and it is
specific language; it is being used somewhere else; it is
nothing we have to reinvent; it is language that is there; it
has got material behind it; it can easily be plugged into this
statute.
Dr. Weldon. Thank you, Mr. Chairman.
Mr. Mica. Thank you, and thank you for leading a discussion
on the questioning that I think will be helpful as we try to
find some way to fix a well-intended program that has some very
distinct problems.
The only question I might have is if we could take this
totally out of the legal realm. Dr. Kinsbourne, you thought it
might have to be a little of both, but if this could be made
strictly an administrative process and then give recourse, if
there isn't satisfaction, into the legal realm, do you think
that might be something that could be done?
Dr. Kinsbourne. I think yes, if the potential petitioners
had some guidance counseling from informed people. Some people
simply don't have very clear ideas either way of what is a
vaccine injury. As you have heard, often doctors don't have a
clear idea of what is a vaccine injury; in fact, the
information to doctors has mostly been, ``Oh, vaccine injuries
are overstated.'' That is more what they are being told than
how to recognize them when they occur. So, somebody with, I
think, both medical and legal knowledge should be able to
advise them. It doesn't have to be in legal proceedings.
Mr. Shoemaker. I think given the history--thank you, sir--I
think given the history of the way the Department of Health and
Human Services has administered this program, making it more
restrictive and more difficult and more litigious and more--
very difficult to prove cases--I think if the administrative
process takes lawyers out of it and if claimants don't have
lawyers representing them, then all I can say is I will be
waiting at the other end to file their civil lawsuits.
Mr. Mica. Dr. Gale, do you want to respond?
Dr. Gale. I am not sure that I have more to add to that.
Mr. Mica. Well, I think you have pointed out that we could
establish some broader parameters for acceptance as possible
victims of vaccine injury, and I think you both have--both Dr.
Gale and Dr. Kinsbourne have pointed out the difficulty in
pinpointing the connection, although you make some assumptions
within certain parameters. I think you said that you could
identify those cases and medically it may be a guesstimate but
a pretty accurate assumption. And some that fall outside of
those parameters could be handled through litigation, but for
the most part we could probably expedite many of these cases by
going to an administrative procedure.
If we had a panel of medical experts to--if we set the
general parameters and made them broad, as you said, Dr. Gale,
and then had a review by a panel of medical personnel, then we
went basically to a mandatory arbitration or mediation, do you
think that would work, Dr. Kinsbourne?
Dr. Kinsbourne. If the panel were given very clear
guidelines as to the criteria that they should adhere to,
doctors will--then naturally think the way they do. They will
be skeptical; they will be critical; they will have a high
standard for accepting any diagnosis, and it will be the
easiest thing in the world for them to say, ``I am not
convinced,'' and so on. They would have to be told very
specifically at what level of confidence a positive decision
needs to be made. If that were done, I think it would work.
Mr. Mica. Dr. Gale, did you want to respond?
Dr. Gale. I would agree with that. Like Dr. Kinsbourne, I
have reviewed records for the Department of Health and Human
Services that seemed immediately, upon review, to fulfill the
qualifications in the table and in my opinion were compensable.
That is a very short process. You read the record, make a call
later that day, file a report. That is compensable.
If you keep the concept of a table, that is, if there is a
reference to which injuries or conditions are going to be
compensable, which means that you will not compensate others,
and if there is going to be a time window, which means that
somebody will be an outlier, that is the consequence of that.
If the window is at 3 days, if you are on the 4th day, you will
be an outlier. That will change the nature of how your petition
is handled. If you expand the window to 7 days, 8 days will
make you an outlier.
So, if you keep those two elements of the table for
physicians to refer to, and then you will have to decide do you
or don't you want to keep the concept of factors unrelated to
the vaccine as part of the process for physicians to review.
That is, if we can clearly identify that a youngster has a
tumor that accounts for his or her neurological disorder, do we
take that into consideration in deciding whether a case is
compensable or is it sufficient for the disorder occurring
within a time window to simply occur, in which case the case
would be compensable in spite of the tumor or in spite of the
automobile accident?
If you eliminate, as preposterous as this sounds, but it is
preposterous examples that usually help us to focus on what we
are doing, a preposterous example would be a youngster who gets
an immunization for school at age 5 or 6 on a Monday and is
struck by an automobile on Tuesday and goes into a coma and
comes to the hospital and is never well again. If there is no
factor unrelated to the vaccine as part of the reference table;
that is, if you have a condition, encephalopathy, that occurs
within 3 days of the administration of the vaccine, and in this
case, in my hypothetical, it would--that would become a
compensable case, and that is fine, if that is what you intend
to do. You would need to codify those guidelines so that if
physicians are going to participate in the process, they know
what you want of us.
Mr. Shoemaker. To expand a little bit on that, I think I
would like to represent the outliers in this case. I will never
forget a case I had where it was determined that the residual
seizure disorder started 75 hours after the vaccination instead
of 72 hours after. So, I would certainly encourage expanding
the table, including these cases that I talked with Dr. Weldon
about where there are--where there is this information that it
is biologically plausible, there are case reports, people
suspect there could be relationship, but it hasn't been proven
or disproven because there have been no epidemiological
studies. Get all these things into the table, grossly reduce
the alternate cause aspects of the table, and if those two
things are done, I would say, yes, I am all in favor of
improving the table to include more cases, to make it a more
inclusive program.
But then the next step is, I think you have to go beyond
that for these other cases, and there are going to still be
causation-in-fact cases out there that don't fit whatever table
you come up with. I am still encouraging you to look at what I
have written about making it clear that this is not a waiver of
sovereign immunity, this is a remedial program; making it clear
and changing that burden of proof to what is used in veterans'
cases, and doing the things that I have asked in here.
And that brings me really to an issue of the statute of
limitations. There are all kinds of statutes of limitation in
these cases, and one of the things I keep thinking about as I
puzzle over what to do with them is why do we have a statute of
limitations? This is a compensation program. Leave the States
to take care of the statutes of limitation as to whether people
can file civil lawsuits. That is their job; let them do it.
This program won't affect it.
I suppose as long as you are in the program, it will toll
the State statute of limitation. That is fine; I agree with
that. But why do we even have a statute of limitations in this?
I get calls all the time. I get calls from people who were
vaccinated August 5, 1997, with hepatitis B vaccine. They had
to file their claim by August 6, 1999, whereas somebody
vaccinated 2 days later had until August 7, 2000. Now, that
doesn't make any sense. The only purpose of that is to get
lawyers in trouble and have them call their malpractice carrier
because they screwed up. It doesn't make any sense at all.
I applaud the Department of Justice for asking for a 6-year
statute, but why have any statutes of limitation at all? I am
getting calls from people--now, in the literature, it is coming
out about whether or not MMR vaccine causes autism. Well,
eventually that may be proven, and if it is proven, what about
all those old cases that had autistic children from MMR
vaccine? Are they out of luck or can they file the claim?
You are going to have all kinds of problems--if you change
the statute of limitation to 6 years, what do I tell the person
who was dismissed 2 years ago because he came to me 3 years and
6 days after the statute of limitation, and his child's
seizures had started 3 days after the vaccination? So, when he
walked into my office the first time it was too late. I filed
the claim; I got dismissed, because it was too late. I was
bound to 3 years.
Now, if you add 6 years soon enough, I should be able to
refile his claim I hope. But what if you don't get it added
until it is more than 6 years since the vaccine? Now, I can't
file his claim, but I can still go into civil court and sue,
because it is a child, and in most States, the statute of
limitations is tolled during minority. It makes no sense.
Anybody that thinks this an easy program to work in as a
lawyer--I can guarantee you there are plenty of pitfalls in
this program, and we all are looking over our shoulder every
day because of the myriad of problems that we have like this.
And I could go on and on and talk about them, but why even have
a statue of limitations?
Mr. Mica. Mr. Burton.
Mr. Burton. Let me just say, Mr. Shoemaker, and I
apologize, I just walked in, but if you could send the chairman
of the subcommittee and myself a list of things that you think
could or should be done to eliminate these inequities, we will
see if we can't work on it together----
Mr. Shoemaker. Thank you, sir.
Mr. Burton [continuing]. Mr. Mica and myself, to get them
corrected.
Mr. Shoemaker. Thank you, sir.
Mr. Mica. I would like to thank each of the panelists on
our second panel for their insight and for their
recommendations. We are going to try our best to see how we can
reform this Vaccine Injury Compensation Program that was set up
with good intent but has gone astray here.
We particularly appreciate Dr. Kinsbourne and your
besmirched reputation having dealt with our committee. We hope
that you recover, but professionally we admire you and thank
you again for offering your testimony. Once again, sometimes
people come back for a second dose of abuse.
Mr. Chairman.
Mr. Burton. Yes, I am sorry I missed your testimony, Dr.
Kinsbourne. My assistant just told me how you were
discriminated against, I guess you would say, because you
testified before our committee. We will be back in touch with
you and talk to you about that as well. Thank you, sir.
Dr. Kinsbourne. Thank you, sir.
Mr. Mica. Thank you. We will dismiss this panel and call
our third panel.
Our third panel consists of two witnesses, Mr. Thomas E.
Balbier, Jr. He is the Director of the National Vaccine Injury
Compensation Program with the Department of Health and Human
Services. The second witness is Mr. John L. Euler, and he is
the Deputy Director of the Torts Branch, Civil Division of the
Department of Justice.
Gentleman, if you will stand and be sworn.
[Witnesses sworn.]
Mr. Mica. The witnesses answered in the affirmative.
As I said, if you have any lengthy statements or
documentation you would like to be made part of the record, on
unanimous consent request, that will be done.
First, we will recognize the Director of the National
Vaccine Injury Compensation Program, Mr. Thomas E. Balbier, Jr.
You are welcome, sir, and recognized.
STATEMENTS OF THOMAS E. BALBIER, JR., DIRECTOR, NATIONAL
VACCINE INJURY COMPENSATION PROGRAM, DEPARTMENT OF HEALTH AND
HUMAN SERVICES; JOHN L. EULER, DEPUTY DIRECTOR, TORTS BRANCH,
CIVIL DIVISION, DEPARTMENT OF JUSTICE
Mr. Balbier. Good afternoon, Mr. Chairman and members of
the committee. I am pleased to be here this morning to talk to
you about the National Vaccine Injury Compensation Program.
With me to provide additional information if needed, are Dr.
Geoffrey Evans, the Medical Director for the program, and Mr.
David Benor from our Office of the General Counsel.
The National Vaccine Injury Compensation Program has been
hailed by Secretary Shalala as the cornerstone of our Nation's
successful childhood immunization program. It provides a unique
service to families suffering through one of the most difficult
experiences imaginable. It makes a system available through
which families can receive financial help in the most efficient
and fair manner possible, while still preserving their rights
to file suit in the tort system.
The program significantly reduces, but it cannot eliminate,
the tension and adversity inherent within any litigation
process. As with every Federal benefit program, there are going
to be eligibility requirements which seem unfair to some
applicants. I can assure you that everyone involved in the
administration of the program makes a concerted effort to
ensure that fairness is the operating principle in dealing with
every family filing a claim under the program.
We have been listening to concerns raised by those who may
feel the system has been unfair and more adversarial than they
had expected. It is critical to remember that although the
program is far less adversarial than the tort system, it does
encourage anyone who believes they have a condition caused or
aggravated by a childhood vaccine to file a petition for
compensation. Petitioners' rights are vigorously defended and
advocated by their attorneys, who are paid regardless of
whether petitioners are compensated. However, it was never
intended to serve as a compensation source for a wide range of
naturally occurring illnesses or conditions, which
unfortunately affect many of our children.
The process of determining whether, and at what level,
compensation should be awarded will always involve conflicting
opinions and a natural tension. This has been recognized by
everyone involved in the day-to-day administration of the
program as well as by the Advisory Commission on Childhood
Vaccines [ACCV], which was established by the act to ``advise
the Secretary--of HHS--on the implementation of the program.''
The members of the ACCV include parents of children injured
by vaccines, their attorneys, representatives of vaccine
companies, and recognized medical experts in childhood
diseases. This diverse body has provided constant oversight of
the operation of the program, advised the Secretary on each and
every modification of the vaccine injury table, and has made
numerous legislative and administrative recommendations over
the years aimed at improving the operation of the program.
Most recently, it developed and approved a series of
recommendations that form the basis for legislation recently
proposed by the Secretary of HHS. These proposals include many
enhancements aimed at making the program more streamlined and
less adversarial for its intended beneficiaries. The proposals
would double the statutory time limit for filing a claim,
expand compensation to families, and simplify the process for
adjudicating claims.
I would like to talk for a minute about concerns related to
the Vaccine Injury Compensation Trust Fund. The trust fund was
established to ensure that a constant source of funding would
be available for the payment of compensation under the program.
The trust fund is financed by an excise tax of 75 cents per
dose imposed on each vaccine covered under the program. At this
time, the trust fund balance is in excess of $1.4 billion.
During fiscal year 1998, the trust fund received total income
of $183 million, with $116 million coming from excise tax
revenue. The remaining $67 million came from interest on the
balances in the trust fund and more than covered the 1999
outlays for awards, and for attorney fees and costs, of just
less than $50 million.
The trust fund should be viewed as a specialized public
health insurance fund, maintained with adequate reserves to
handle liability exposure as new childhood vaccines come to the
market and as important ongoing surveillance activities of the
Public Health Service spawn new scientific studies of
theoretical vaccine-related adverse events.
Recently, coverage under the program was expanded to
include four additional vaccines for which 279 petitions have
been filed. In addition, there are more than 300 vaccines in
various phases of research and development, some of which may
eventually be added for coverage under the program and result
in increased liability.
There is good reason for the public to have confidence in
the overall operation of the program. There have been two
comprehensive, independent program evaluations conducted since
the program was first enacted. The first, conducted by the HHS
Office of Inspector General in 1992, concluded, ``The case
process is efficient; the program is well organized with good
procedures; no unnecessary duplication of effort exists; roles
and responsibilities are clearly defined; coordination and
communication among the Federal agencies is strong, and
petitioners and their attorneys are generally satisfied with
their experience in the program.''
The second study was done just last year when the Federal
Judicial Center completed a report on the program, which
concluded, in part, that ``the case-management innovations and
handling of expert testimony function well in the VICP.''
Currently, the General Accounting Office is conducting a review
of the program at the request of Senator Jeffords, and the GAO
has indicated that the results of the review should be released
by the end of this year.
All indications are that this program is working very much
as intended by Congress. There will always be program areas
that can be improved, and we continue to implement initiatives
to address these areas. The program has always been open to
advice from all interested parties, and mechanisms are in place
to assure that the varied interests of families, health care
professionals, attorneys, and the vaccine industry are
represented at a regular public forum.
The ACCV, with its widely diverse membership, brings a good
balance of perspective and has been instrumental in identifying
program improvements that have consensus support. With strong
ACCV support for the administration's proposed legislative
agenda to make this innovative program even better, it is now
up to Congress to move these important changes forward as
quickly as possible so that our children can reap the benefits
of the program ``in the most efficient and fair manner
possible.''
Thank you once again for allowing me to come here today to
tell you about the National Vaccine Injury Compensation
Program. I will be pleased to answer any additional questions
which you may have.
[The prepared statement of Mr. Balbier, Jr., follows:]
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Mr. Mica. Thank you, and we will suspend questions until we
have heard from our other panelist.
Mr. John L. Euler, Deputy Director of the Torts Branch,
Civil Division, Department of Justice, you are recognized.
Mr. Euler. Thank you, Mr. Chairman and members of the
subcommittee. I appreciate the opportunity to appear before you
today. So that I may limit my remarks, I request that my full
written statement be entered into the record.
Mr. Mica. Without objection, so ordered.
Mr. Euler. Thank you, sir.
Congress in the 1980's was faced with a looming public
health crisis concerning immunizations which involved complex,
hotly debated medical issues overlaid with the emotion of
personal loss and tragedy in individual cases. In order both to
provide a more feasible avenue of compensation and stabilize
the national immunization policy, Congress established this
program.
Petitioners are afforded a less adversarial system with
free counsel in which their meaningful participation is
assured. The debate, the emotion, the complexity of the cases
were not eliminated and never will be, but an effective
mechanism is in place. As a result, almost 5,000 cases have
been resolved and numerous families compensated while the
supply of life-saving vaccines has been assured.
The act of 1986 created a much needed alternative to
products liability and medical malpractice litigation for
vaccine injuries. It removes many of the more difficult
elements of proof that plaintiffs faced in traditional civil
court. The program is no-fault. In other words, claimants need
not establish that the vaccine was defective or that the doctor
was negligent. The process itself is characterized by
streamlining features. Neither the rules of evidence or
procedure apply rendering virtually all evidence that
petitioners seek to present admissible. The special masters
make every effort to allow the parties to present their best
case.
By design, this is not a straight claims process nor
traditional litigation but rather a hybrid system that blends
the best of both, even if it cannot escape entirely the
frustrations inherent in any adjudication. Critical to the
prompt resolution of cases is the completeness of the petition.
This is a front-loaded system. In other words, petitioners are
responsible for identifying the specific nature of their claim
and providing all medical records and related documents. When
the initial filing is incomplete, petitioners are granted
liberal extensions. If there is delay, it is most often because
of an incomplete record or an underdeveloped medical position.
The pace of the process is largely controlled by petitioners.
The role of the Justice Department is to implement the
statute and uphold the provisions of the act. In other words,
we help ensure that compensation is provided to those who meet
the criteria determined by Congress. We are obliged to protect
the trust fund against claims by those who have not suffered a
vaccine-related injury.
In the spirit of the act, we do this in a far less
adversarial manner than defendants in civil litigation. We
participate in an early telephonic conference with petitioners
and the court to discuss the deficiencies in the petition. The
format of the hearings is informal and accommodating. The
hearings are undertaken with a sensitivity to the fact that
these cases involve highly emotional and personal issues often
concerning severely injured children.
With regard to determining compensation, Congress has set
forth a detailed list of compensable items. While it is often
time-consuming, the key is that the program process is far more
thoughtful and tailored than other systems. In most vaccine
cases, the goal is no less than establishing a custom tailored
plan of life time medical care, frequently a cooperative
effort. I estimate that 90 percent of the damages cases are
settled without a hearing.
The Department published a packet entitled, ``Steps to
Streamlining Damages Under the Program,'' which sets forth ways
to expedite the damages phase. We distribute this document to
counsel, and I have copies of it with me today. We also issued
a guide to assist petitioners' attorneys with attorneys' fees
and costs, and I have copies of that as well.
In spite of these numerous accommodations, resolution of
these cases simply cannot always be accomplished quickly. There
exists an obvious tension between efficiency and due process.
The issues can be difficult and complex. The amount sought is
frequently in excess of several million dollars.
In short, I believe the program is working as designed. As
with any Government program, with specific criteria, there will
be applicants who are dissatisfied, even among those who are
awarded compensation. Yet we cannot ignore the statutory
criteria or the consensus of the scientific community on
medical causation issues. It is a program that relies heavily
upon the most current and accurate scientific evidence
available--it does in fact rely on the most current and
accurate scientific evidence available.
In resolving claims, the court, consistent with statutory
guidelines, does not require scientific certainty, simply a
preponderance of the evidence.
Mr. Chairman, thank you again for this opportunity. I will
be pleased to answer any of your questions.
[The prepared statement of Mr. Euler follows:]
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Mr. Mica. Thank you, and I would like to yield now to the
chairman of the full committee for questions.
Mr. Burton. Mr. Euler, I understand your employee, Ms.
Hewitt, was the one who challenged the credibility of Dr.
Kinsbourne when he testified recently at a case. Can you tell
me why that happened?
Mr. Euler. According to Dr. Kinsbourne, Mr. Chairman, Ms.
Hewitt entered into the record the fact that Dr. Kinsbourne had
testified.
Mr. Burton. What does that have to do with anything?
Mr. Euler. Well, it has to do with cross examination.
Normally, in cross examination, previous testimony of a
witness, things that have been published, things that they have
said have been used. Certainly, petitioner's counsel will use
things that experts have said in an effort to cross examine.
Mr. Burton. So, it was assumed that he had a bias, because
he testified before our committee and what he said?
Mr. Euler. I have not seen the record. I understand from
Dr. Kinsbourne that she argued bias. Now, this is a pending
case----
Mr. Burton. Yes.
Mr. Euler [continuing]. And I hesitate to talk about a
pending case.
Mr. Burton. Ms. Hewitt works for you, doesn't she?
Mr. Euler. Yes, she does.
Mr. Burton. Here is what she said: ``The fact that he
recently testified before Congress about a number of issues,
but in particular about his views on the problems with this
program, I think also shows that to some degree he is an
advocate on behalf of the petitioners, and Dr. Holmes is not.''
I didn't know that testifying before Congress impeded
people's ability to testify in courts of law.
Mr. Euler. Well, I----
Mr. Burton. I think you ought to talk to Ms. Hewlitt--
Hewitt, or whatever her name is. I mean, it seems to me, you
don't know everything that she said, and she is your employee,
isn't she?
Mr. Euler. That is correct.
Mr. Burton. And you haven't talked to her about this?
Mr. Euler. I have not. But I appreciate--and I think that
point that Dr. Weldon made is a good one. I think he raised the
point that this might chill expert testimony. And in that
respect, I think we are duly rebuked. I don't think we should
be----
Mr. Burton. Well, we have had problems like this with the
Justice Department before.
There have been 6,000 cases filed, 3,500 dismissed, 1,400
settled, and 1,100 pending according to the records we have.
This is supposed to be a non-adversarial process, and yet when
you were testifying, Mr. Balbier, you said it is less
adversarial. It is supposed to be non-adversarial, isn't it?
Mr. Balbier. That is not my understanding of the statute at
all.
Mr. Burton. Well, Mr. Waxman who wrote the law said it was.
Mr. Balbier. I heard Mr. Waxman say that the program is
supposed to be less adversarial than the tort system. If it
truly were a non-adversarial system----
Mr. Burton. I guess we could go back and read the record
earlier today, but I was sitting here, and I am pretty sure he
said non-adversarial. But, anyhow, let us not dwell on that.
Mr. Balbier. I would think that if it truly were a non-
adversarial system, you would not have advocates representing
the families that are affected by childhood vaccines.
Mr. Burton. The reason you have advocates appearing on
behalf of these people is because their kids have been harmed,
and they are not getting proper treatment by the Federal
Government, and because of that, they have to hire attorneys.
You know, my two grandkids, we have tried to find
attorneys. Do you know how hard it is to find an attorney to
take one of these cases because of the way you guys run them
around? They don't want to do it. They don't want to take 2, 3,
or 4 years, because they know you can't afford to pay it.
You know, you said that among those that participate in
setting the standards in the decisionmaking process were the
vaccine-producing companies. Is that correct?
Mr. Balbier. That is correct.
Mr. Burton. Why?
Mr. Balbier. The statute requires, or sets out who serves
on the Advisory Commission of Childhood Vaccines.
Mr. Burton. And the vaccine companies are required to sit
on that board to make----
Mr. Balbier. Yes, they are, sir.
Mr. Burton. Well, I think that is something that should be
looked into.
Why should those who have a vested interest be involved in
the decisionmaking process. The reason this system was set up
in the first place was because the pharmaceutical companies
said that they were in jeopardy of having severe lawsuits that
could jeopardize the viability of the companies.
And so what Congress said was, ``OK, we are going to try to
help you out by coming up with a non-adversarial situation,
procedure, where you won't be jeopardized, but money will be
put into a fund for each shot that is given to protect the
people who might be harmed.''
And, so it has become adversarial, and they are involved in
the decisionmaking process. That makes no sense. It just
doesn't make any sense to me. They should not be involved. You
should have medical professionals and scientists who
understand, like Dr. Kennedy who appeared before this
committee, who said that 50 percent of the DPT shots--50
percent of those who got the DPT shot had adverse effects. He
said 50 percent, and he is a scientist that has been working on
this at the University of Oklahoma.
And yet the people who make the DPT shots can be involved
in the decisionmaking process when we are talking about
settlements. I don't understand that. And the DPT shots are
still being given even though we have known for years that they
have 50 percent side effects; some severe, some not so severe.
I mean, these pharmaceutical companies make major
investments in vaccines; I understand that. And they have a
very strong financial interest. And if something goes wrong
with these vaccines and they are taken off of the market, they
suffer severe losses. And, so I can understand why they want to
keep those on the market and why some people maybe--maybe--at
HHS and FDA protecting and allowing them to give things that
are dangerous to people these vaccines, these kids.
And, so for them to be involved in any way in the
decisionmaking process doesn't make any sense to me, because
they do have a vested interest.
Mr. Balbier. I would agree with that. They are not involved
in the decisionmaking process, sir. They are represented on the
Advisory Commission, which is strictly advisory. They do not
make any decisions through the adjudicative process, but they
do make recommendations to the Secretary.
Mr. Burton. I am sure they do.
Mr. Balbier. And there is one person representing vaccine
companies.
Mr. Burton. Yes, I know.
Mr. Balbier. We also have petitioners, attorneys; we have
two parents who sit on that----
Mr. Burton. You know, Shakespeare said, ``A rose by any
other name would smell as sweet.'' If they are involved in the
process at all because they have a vested interest, it is a
mistake, especially those who have a lot of money invested in
vaccines that are questionable.
We heard just a little while ago--and I am sorry if I am
going too long, Mr. Chairman--we heard just a little while ago
about a fellow whose child suffered from polio, because they
gave him live vaccine, and they have known for decades that
there was that risk, while at the same time, for decades, they
have dead virus vaccines that could be given to people that
were not nearly as risky.
Why was that live vaccine kept on the market all those
decades? Why is the DPT shot being used today when we had
people testify here before the full committee that it was a
problem, a danger? And then on the Advisory Committee you have
the pharmaceutical companies. I think it is something we need
to take a hard look at.
One-quarter of the claims have been adjudicated and
finalized--one-quarter. So, we have 3,500 people who thought
they had a legitimate case in a non-adversarial system. Their
case was dismissed--I don't know what happened to them--1,100
are pending, and out of 6,000 only 1,400 have been settled.
I just don't understand that. Are the decisions made by
this board objective or subjective?
Mr. Balbier. I would say that the recommendations made by
our Advisory Commission are as objective as they can be, and in
fact whenever anybody who serves on that commission does have a
vested interest on any matter that is being voted upon, they
recuse themselves from a vote on that matter, which has
happened frequently, especially with the vaccine companies'
representatives. For any issue that involves the vaccine made
by the company that they represent, they do not vote on that
issue; they never have.
Mr. Burton. OK, we have--my staff just told me they have 24
people on one of the decisionmaking bodies, and 11 of those
have received money from the pharmaceutical companies that were
being investigated. That is almost half. You say they all
recuse themselves?
Mr. Balbier. No, that is a different advisory committee, I
believe. I believe the staff perhaps is referring to the
Advisory Committee on Immunization Practices, which makes
recommendations on immunization policy; that is, which vaccines
are given and when, to children.
Mr. Burton. It says it is an FDA advisory committee,
Vaccines and Related Biological Products Advisory Committee,
Center for Biologic Evaluation and Research.
Mr. Balbier. That is yet again another advisory committee
involved in immunization, which makes recommendations to the
Food and Drug Administration for licensing.
Mr. Burton. Can you give me the makeup of the committee we
are talking about?
Mr. Balbier. Yes, I can. The Advisory Commission----
Mr. Burton. How many of those people are physicians or
scientists?
Mr. Balbier. I'll be happy to answer. The Advisory
Commission on Childhood Vaccines, by design of Congress, is a
very diverse group. Its purpose is to make recommendations to
the Secretary on the operation of the Compensation Program. It
is comprised of nine voting members--three doctors, three
lawyers, and three members of the general public.
Mr. Burton. OK, now the three doctors, where do they come
from?
Mr. Balbier. Two of them have to be pediatricians; one does
not.
Mr. Burton. Do they have anything to do with HHS or FDA or
any of the Government agencies?
Mr. Balbier. That is a tough question to answer. By their
very service on the commission----
Mr. Burton. I don't know if it is very tough or not. Do
they have anything to do with FDA, HHS, or any governmental
agency?
Mr. Balbier. Many of the members on our commission have
served on other advisory committees, for example. The current
members in the medical community--Dr. Sam Katz has served on--
--
Mr. Burton. How are they compensated?
Mr. Balbier. They are compensated for their actual service
that day on the Advisory Committee at a rate of compensation
that is set in the statute.
Mr. Burton. Do any of them serve on any advisory boards or
any pharmaceutical advisory boards connected with the
pharmaceutical industry?
Mr. Balbier. If they do, they have to indicate that to us.
Mr. Burton. Well, I would like to have, for the record, the
backgrounds, the biographical sketches, and their connections
for all three of those people, if it is possible.
Mr. Balbier. OK.
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Mr. Burton. Then you have three lawyers. Do the lawyers
represent any agencies of the Federal Government in addition to
serving on these boards?
Mr. Balbier. No. The statute requires that one of the
lawyers has to be a petitioners' lawyer, somebody who
represents petitioners under the compensation program. One has
to be a lawyer who represents a vaccine company, and then----
Mr. Burton. One of them has to be a lawyer that represents
a vaccine company.
Mr. Balbier. That is in the statute.
Mr. Burton. Why?
Mr. Balbier. Because it is in the statue.
Mr. Burton. That seems, again, like a possible conflict of
interest, because they represent a vaccine company who has a
vested interest in what is paid and what isn't paid and where
they are sued. I think we need to look at that.
I would like to know who that lawyer is and what companies
he represents.
Mr. Balbier. OK.
Mr. Burton. OK?
Mr. Balbier. His name is Paul Strain.
Mr. Burton. Well, I don't want it right now.
Mr. Balbier. We can provide that for you.
Mr. Burton. I want to have the complete background--what
companies he represents, what his background is, and whether or
not any of the vaccines that are under investigation as far as
compensation being paid to patients.
Mr. Balbier. Right.
Mr. Burton. And if he has represented in the past or
currently any of those companies--in the past or currently.
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Mr. Burton. OK, now what about the third lawyer?
Mr. Balbier. The third lawyer doesn't have to be of any
specified affiliation.
Mr. Burton. Could he be one that worked for a
pharmaceutical company?
Mr. Balbier. No, in my view, that would exclude him from
being eligible.
Mr. Burton. Well, I want to check on that too. I want the
same on his as well. And, also the lawyer that represents the
families, I want to find out if any of those lawyers had any
connection whatsoever with any pharmaceutical companies in the
past.
I would like to have that in detail, and if I don't get it,
we will subpoena them. I am prepared to subpoena them, so you
be sure to tell me that.
Now, what about the three civilians?
Mr. Balbier. There are three members of the general public.
Within that category----
Mr. Burton. Do any of those have any connections with
pharmaceutical companies?
Mr. Balbier. I can't answer that question.
Mr. Burton. Well, I want that too. I want to know if
anybody that serves on this advisory panel--any of them--have
any connection to pharmaceutical companies, have ever received
any moneys from pharmaceutical companies, represented them in
any way, and we are prepared to send subpoenas to any of them
if we don't get complete backgrounds on them. OK?
I think I have talked long enough, Mr. Chairman.
Mr. Mica. Thank you, Mr. Chairman.
I have some questions, first, for Mr. Balbier. You have
resolved 1,400 cases in which there has been compensation. Is
that correct?
Mr. Balbier. That sounds about right.
Mr. Mica. And over what period of time?
Mr. Balbier. That is over the entire history of the program
since it was first created.
Mr. Mica. Is that 1988, was it, or 1987? Are we talking
about 140 cases a year?
Mr. Balbier. There are about 100 or so claims filed, on
average, each year, but the vast majority of claims filed were
for years prior to the creation of the program. There was no
statute of limitations.
Mr. Mica. Right now, there are about 100 cases filed per
year?
Mr. Balbier. Roughly. This year is an exception, of course,
because----
Mr. Mica. Tell me about your budget.
Mr. Balbier. Sure.
Mr. Mica. And you said this year you awarded how much in
compensation?
Mr. Balbier. So far this fiscal year, we have paid out
$47.7 million for the----
Mr. Mica. That would be just through to August?
Mr. Balbier. That would be through the end of August, and
that is just for the pre-1988 program.
Mr. Mica. Your last complete year of awards, how much was
that? That would be 1998?
Mr. Balbier. A total of $135 million divided between the
pre-1988 program and the post-1988 program--$79 million for the
pre-1988 program and $56 million for the post-1988 program.
Mr. Mica. How big is your staff?
Mr. Balbier. My staff is about 21 employees.
Mr. Mica. Twenty-one employees. Full-time. And your
expenses in the last fiscal year that you have a complete
record for, I guess that would be 1998?
Mr. Balbier. That would be $3 million, and that includes
not only the funding for our staff but also funding for all the
expert witness testimony that is provided to the court as well.
Mr. Mica. So, $3 million and hundred and some million in
awards--$135 million?
Mr. Balbier. Yes, sir.
Mr. Mica. Have there been any dramatic changes in the size
of staff or expenditures for administrative costs of late, the
last couple of years?
Mr. Balbier. No, sir. It has been $3 million since 1994.
Mr. Mica. Pretty much steady? How many of your staff are
dedicated to analyzing the caseloads and outcomes?
Mr. Balbier. We have physicians that work for the staff,
and currently we have three full-time physicians on staff right
now who review claims.
Mr. Mica. Are you seeking to add staff in the near future
or do you have staffing requirements?
Mr. Balbier. No, we are not seeking to add new staff.
Mr. Mica. And how do you determine the amount the medical
reviewers are paid?
Mr. Balbier. It is really set by the standards used
Government-wide for physicians.
Mr. Mica. There has been--there was testimony earlier about
the change in table eligibility as the result of changes in
table. What is the difference in caseload before and after--was
it 1994 or 1995--1995, March 1995 table changes? Was there a
substantial change in the number of cases before and after?
Mr. Balbier. There really isn't; no, sir. The number of
claims filed in fiscal year 1994, which was the year before the
table change----
Mr. Mica. And how many was there?
Mr. Balbier [continuing]. Was 106. The number of claims
filed during 1995 did increase to 179, and 75 of those claims
were claims that were filed for the period of time between when
we published the final rule amending the table and the 30 days
later when it went into effect. So, we received a number of
claims that were filed clearly to get within the guidelines
under the original table. And, so the claims went down the
following year to 84 and then picked back up to a level of 103
the year after.
Mr. Mica. Now, you cited a couple of reviews of this whole
process that have been done, and I guess there is one ongoing.
I guess the Senate has requested a review also. And you say for
the most part most folks who have had to deal with the fund are
satisfied. You heard dissatisfaction about the length of time,
particularly one case that was brought to our attention--the
Mulhauser case--which took some 6 plus years.
I think that you are one of the two witnesses that
testified that some of the delay was due to the victim as
opposed to the Department. How do you respond to the charges
from the victim that the delay is due to the Department?
Mr. Balbier. One of the difficulties I think that we have
in the damages process, which as I understood her testimony,
the part of the process that she said took a rather lengthy
time, is that from the petitioner's standpoint and from their
attorneys who represent them, their job is to get as much money
for their client as they possibly can.
On the Government side, we have a different task. Our task
is not to limit compensation to pay out as little as possible.
Under normal litigation, that would be the role of anybody who
is sued in any sort of a lawsuit, but that is not our role.
Instead, our role is to try to provide a reasonable level of
care for the vaccine-related injuries.
I think that is perhaps the reason for the problem. Not
only do we have to develop a life care plan that meets the
requirement of the statute, and that provides for all the
various elements of compensation in the statute, but we also
have to try to figure out which items of care are related to
the vaccine injury and only pay for those injuries.
Mr. Mica. Well, it sounds like a lot of--there was a great
deal of dispute, at least in this case, about small ticket
items as opposed to the larger picture and also giving sort of
benefit of the doubt to the petitioner.
Is there any way that we can speed this process up or make
it less contentious and adversarial?
Mr. Balbier. There is. We have been looking at this, and
our Advisory Commission has been looking at this issue to try
to speed up the whole process.
Mr. Mica. Does that mean a statutory change?
Mr. Balbier. Yes, it does, although we have done a number
of things administratively to try to speed up the process as
much as we can.
However, I think to view the litigative process--and it is
a litigative process--with only an eye toward speeding up the
process, could create some problems that we may not want to
create. In other words, we could have a speedy process, but
then people's rights would not be protected.
Another difficulty, quite frankly, is the time it takes to
negotiate damages on a claim--and that is done by the
Department of Justice trial attorneys--they have to develop a
life care plan that will meet the needs of that child for the
rest of their life. Oftentimes it is in the interest of the
petitioner to delay that so that they can see how the child
develops. That is done as part of their strategy.
So, yes, we could make a quicker process, and there are
many ways that you heard earlier individuals testify that could
make it quicker, but in so doing I think we have to be very
careful so that we don't sacrifice the rights of people to get
what they truly deserve under the program.
Mr. Mica. Mr. Burton.
Mr. Burton. I find that interesting when we have deadlines.
My two grandchildren, we had to file--we found out the week
before the deadline that they had to file. And if we had gone
past that deadline, I guess we would have had no recourse--the
week before. So, I mean, I am glad you have this concern about
being fair to these people, but if you only have a certain date
that you have to comply by, it kind of leaves people out in the
cold.
This is supposed to be a no-fault system, and you keep
talking about litigation. I just don't understand that. I mean,
it was designed to be a no-fault system. Why litigation?
Litigation denotes adversarial problems--an adversarial
situation. That doesn't sound like no-fault. You can answer
that in just 1 second.
How much, Mr. Euler, will it cost to care for an injured
child for the lifetime of that child?
Mr. Euler. It depends on the child, Mr. Chairman.
Mr. Burton. Give me a rough idea, say, for one that lives
to be 25.
Mr. Euler. I can't. It is very hard to have a hypothetical,
because each child is different.
Mr. Burton. No, but we have had some children here today
who have had some severe problems. I have a severe problem in
my family. We have already laid out several thousand dollars.
And I know that a lot of families can't afford that. So, what
are they to do?
If the vaccination was responsible for it and we don't find
out for 10 years and the statute or the time period runs out,
what are they to do? Go to SSI?
Mr. Euler. Congress has the ability to change the statutory
criteria, which we are charged with implementing. We have
already recommended that the statue be essentially doubled, the
statute of limitations, from 3 years to 6 years.
Mr. Burton. Why not just take the lid off of it?
Mr. Euler. That is something Congress has the power to do.
Mr. Burton. Would you think that would be a good idea?
Mr. Euler. I think we would have to consider it. I think
every program has time limits. Every program anywhere----
Mr. Burton. But you don't know how a child is going to--I
mean, the child may not have a problem that is visible for 5,
6, 7 years, and then all of sudden the statute has run out, and
that child is ruined for life, and the parent has no resources
to take care of it.
Mr. Euler. The statute begins to run from the onset of the
condition, now, whenever that it is. It doesn't necessarily run
from the date of vaccination, though there can be debate over
when that onset is, but it may be several years out.
Mr. Burton. Mr. Chairman, I thank you very much. It sounds
like to me we are going to have to come up with some amendments
to the current statute, and we have to do it relatively soon.
Thank you, sir.
Mr. Mica. Thank you. The President in an Executive order in
1996 recommended agencies adopt alternative dispute resolutions
and that we try to proceed in that fashion.
Has the Department of Justice or HHS instituted a formal
program of alternate dispute resolution with regard to the
Vaccine Compensation Program?
Mr. Euler. Much of the process itself has elements of what
we call ADR. For example, I referred in my testimony to that
initial telephone conference that the special master convenes
with the petitioner and with Justice counsel. What is done
there is the petitioner is advised of the deficiencies in the
complaint and how they can go about fixing it. I am not aware
of any other system that does that. And that type of informal
processing exists throughout the program.
The court, in addition, does in fact take additional ADR
steps at times in the damages phase. If it doesn't look like it
is being worked out, we have some success getting another
special master to take a look at the case to try to resolve it.
That has worked out well on occasion, and that is sometimes one
of the things we do.
But this is clearly a less adversarial, informal process,
and there are not rules of evidence, there is not civil
discovery. The idea is to get all of the information out on the
table and then to come to a resolution for that child's care.
That is what we are trying to do. That is not an easy process
for petitioners, I grant that. They work hard at it, but
sometimes it takes awhile.
Mr. Mica. Mr. Balbier, do you keep a log of the cases that
have been resolved and then how--or when they were initiated
and when they were resolved? Do you have such a log from the
time--on each case? Like, this year, you said you resolved,
what, X number?
Mr. Balbier. We have a system, of course, where we input
data----
Mr. Mica. But what I would like----
Mr. Balbier [continuing]. That tracks the date of the
claimant's----
Mr. Mica [continuing]. If you could provide us, just get
this year's or the last year's cases and get us the date when
the claim was instituted and then was--well, we know when it
was resolved--so we could see how much time they were taking
up. If you could provide us with that.
Mr. Balbier. We do track that, and the average is about 2
years.
[The information referred to follows:]
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Mr. Mica. I have additional questions. I do want to also
learn from HHS what you are doing to inform the public about
the program. I can't take any responses at this time, and I am
going to adjourn the hearing. I will leave the record open for
at least 3 weeks by unanimous consent request. We will be
submitting to both the Department of Justice and HHS and the
program a lengthy series of questions for response, to be
included in the record.
I do want to thank both of you gentlemen for appearing with
us today and providing information. Also thank the other
witnesses who participated in the hearing.
Hopefully everyone working together--and I have directed
staff to meet within the next week to come up with some
legislative remedies. I know that some have been recommended to
the Speaker, and we will consult with Mr. Waxman, Mrs. Mink,
and others who have expressed an interest hopefully to come up
with a legislative package that is remedial and hopefully
effective.
There being no further business to come before this
subcommittee at this time, this meeting is adjourned.
[Whereupon, at 1:57 p.m., the subcommittee was adjourned.]
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