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



                               before the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS

                             SECOND SESSION


                           SEPTEMBER 18, 2002


                           Serial No. 107-140


       Printed for the use of the Committee on Government Reform

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

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                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut       MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             PAUL E. KANJORSKI, Pennsylvania
STEPHEN HORN, California             PATSY T. MINK, Hawaii
JOHN L. MICA, Florida                CAROLYN B. MALONEY, New York
THOMAS M. DAVIS, Virginia            ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
BOB BARR, Georgia                    DENNIS J. KUCINICH, Ohio
DAN MILLER, Florida                  ROD R. BLAGOJEVICH, Illinois
DOUG OSE, California                 DANNY K. DAVIS, Illinois
RON LEWIS, Kentucky                  JOHN F. TIERNEY, Massachusetts
JO ANN DAVIS, Virginia               JIM TURNER, Texas
DAVE WELDON, Florida                 JANICE D. SCHAKOWSKY, Illinois
CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
ADAM H. PUTNAM, Florida              DIANE E. WATSON, California
C.L. ``BUTCH'' OTTER, Idaho          STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia                      ------
JOHN J. DUNCAN, Jr., Tennessee       BERNARD SANDERS, Vermont 
JOHHN SULLIVAN, Oklahoma                 (Independent)

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

                            C O N T E N T S

Hearing held on September 18, 2002...............................     1
Statement of:
    Harris, Paul Clinton, Sr., Deputy Associate Attorney General, 
      U.S. Department of Justice, accompanied by John Euler; and 
      William Hobson, Director, Office of Special Programs, 
      Health Services Research Administration, Department of 
      Health and Human Services, accompanied by Tom Balbier......   110
    Zuhlke, Janet, parent of a vaccine-injured child; and Ron 
      Homer, attorney for Thad and Diane Rogers..................    83
Letters, statements, etc., submitted for the record by:
    Burton, Hon. Dan, a Representative in Congress from the State 
      of Indiana:
        Prepared statement of....................................    79
        Various bills............................................     4
    Harris, Paul Clinton, Sr., Deputy Associate Attorney General, 
      U.S. Department of Justice, prepared statement of..........   115
    Hobson, William, Director, Office of Special Programs, Health 
      Services Research Administration, Department of Health and 
      Human Services, prepared statement of......................   125
    Homer, Ron, attorney for Thad and Diane Rogers, prepared 
      statement of...............................................    95
    Waxman, Hon. Henry A., a Representative in Congress from the 
      State of California, prepared statement of.................   152
    Weldon, Hon. Dave, a Representative in Congress from the 
      State of Florida, prepared statement of....................   141
    Zuhlke, Janet, parent of a vaccine-injured child, prepared 
      statement of...............................................    88



                     WEDNESDAY, SEPTEMBER 18, 2002

                          House of Representatives,
                            Committee on Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:10 a.m., in 
room 2154, Rayburn House Office Building, Hon. Dan Burton 
(chairman of the committee) presiding.
    Present: Representatives Burton, Weldon, Duncan, Maloney, 
Norton, Kucinich, and Tierney.
    Staff present: Kevin Binger, staff director; James C. 
Wilson, chief counsel; David A. Kass, deputy chief counsel; S. 
Elizabeth Clay, professional staff member; Allyson Blandford, 
assistant to chief counsel; Robert Briggs, chief clerk; Robin 
Butler, office manager; Nicholis Mutton, deputy communications 
director; Joshua E. Gillespie, deputy chief clerk; Michael 
Layman and Susie Schulte, legislative assistants; Blain 
Rethmeier, communications director; Leneal Scott, computer 
systems manager; Corinne Zaccagnini, systems administrator; 
Phil Barnett, minority chief counsel; Sarah Despres, minority 
counsel, Ellen Rayner, minority chief clerk; and Jean Gosa and 
Earley Green, minority assistant clerk.
    Mr. Burton. Good morning. A quorum being present, the 
Committee on Government Reform will come to order, and I ask 
unanimous consent that all Members' and witnesses' written and 
opening statements be included in the record. And, without 
objection, so ordered.
    I ask unanimous consent that all articles, exhibits and 
extraneous or tabular material referred to be included in the 
record. Without objection, so ordered.
    I want to start off by saying that we have got a war that 
we are dealing with, and as a result, there are briefings going 
on the Hill from Donald Rumsfeld, the Secretary of Defense, and 
some of the other members of the administration. And as a 
result, a lot of the members are diverting their attention to 
those issues.
    I don't want anybody to think that the information that is 
going to be discussed today will be not looked at very closely 
by this committee and the administration just because of the 
war. But I think everybody can understand that things being the 
way they are, things that are very important to us sometimes 
are put on the back burner or sidestepped while we get through 
the critical issues facing the country.
    Over the last year, this committee has been overseeing the 
National Vaccine Injury Compensation Program. We have held two 
hearings and we have introduced legislation. Our concern has 
been that this program has become too adversarial and that 
people who have been injured aren't getting a fair shake. This 
program was intended to be less adversarial than civil 
litigation. It was intended by Congress to provide compensation 
quickly and easily to people who have suffered very serious 
    On close calls, the families are supposed to get the 
benefit of the doubt. Unfortunately, that doesn't seem to be 
    We are going to look at the Rogers case today. It was a 
close call. The Special Master ruled in favor of the family. 
Instead of accepting that decision gracefully, the Government 
has filed appeal after appeal to try to overturn it; and I just 
think that's wrong. That's not how we intended this program to 
    While approximately 1,700 families have received 
compensation under this program, many families have seen their 
cases tied up for years in a system that has become too 
contentious. At last year's hearings, we heard from six 
different families. They all had a very difficult time getting 
through this program.
    We asked two of those families to come back today and 
update us on their cases. The reason we did that is because 
almost 1 year later these cases are still not resolved. They've 
dragged on for 8 to 10 years; and if we want to figure out 
what's working and what isn't working with this program and try 
to fix the problems, then these are the kinds of cases we need 
to take a hard look at.
    Janet Zuhlke is back with us today. Her daughter Rachel was 
severely injured after she received her prekindergarten 
vaccines in 1990. Today Rachel is mentally retarded. She has 
periodic bouts of blindness that are getting progressively 
worse. She has seizures. She's confined to a wheelchair. She 
will need around-the-clock care for the rest of her life.
    A team of respected medical specialists diagnosed her case 
as a vaccine-related encephalopathy, which is a table injury. 
Table injuries are supposed to receive compensation quickly and 
without opposition. Unfortunately, Janet had to fight for 9 
years to get compensation--9 years.
    In July of last year, the Special Master ruled that Rachel 
was entitled to compensation over the strong opposition of the 
Justice Department and Health and Human Services. It has now 
been 14 months since then; and because this system has become 
so complex, Janet and Rachel still haven't received their 
    We are just a week or two away from the tenth anniversary 
of Ms. Zuhlke's filing her petition. To date, she has not 
received any compensation for the table injury her daughter 
suffered. Ten years to settle a table injury was not how 
Congress intended this program to operate.
    I have been told that the Special Master is working very 
hard to move this case forward and get it finished. He deserves 
credit for that. In just the last 2 weeks, they had a hearing 
to try to resolve the remaining disputes.
    I want to be clear on one thing. The purpose of this 
hearing is not to try to influence the Special Master's 
decisions. The Special Masters have to be independent, and they 
have a tough job to do, and we should respect that 
    What does bother me about this case is that the Justice 
Department and the Department of Health and Human Services are 
opposed to paying for the medical treatments that Rachel is 
receiving. She has a team of specialists. They prescribed a 
series of treatments for her to try to keep her condition from 
deteriorating. As I understand it, these treatments are 
helping, and the Government doesn't want to pay for them 
because they are too expensive.
    For 9 years, they fought to deny the Zuhlkes compensation. 
And now for the last year, they've fought to deny her the 
medical treatments her doctors say will help her. For the life 
of me, I can't understand that.
    As I mentioned earlier, the other case we are going to look 
at is the Rogers case. Thad Rogers came here last November from 
Alabama to testify on behalf of his wife Diane. We asked him to 
come back today, but she is too ill, and he couldn't leave. Ron 
Homer, who is the attorney for the Rogers family, will testify 
on their behalf. However, the family has sent a videotaped 
statement that we are going to watch.
    Diane Rogers received a routine tetanus vaccination in 
February 1991. She rapidly developed MS-like symptoms. She's 
now bedridden. The Special Master determined in 2001 that Ms. 
Rogers is entitled to compensation under the program; it took 7 
years to get to that point. Unfortunately, the Government does 
not want to concede on this case.
    As I said before, the Justice Department has appealed this 
decision and they lost. They twice made motions for 
reconsiderations and then were rejected both times and now they 
are planning on appealing again. I just don't see the point of 
dragging this thing out. This family has been waiting for 8 
years. It's time to stop fighting and give them what they 
    As a result of our investigation, we've introduced 
legislation to try to improve this program. It's a bipartisan 
bill. Congressman Waxman and Congressman Dave Weldon and over 
40 of my colleagues have joined me in introducing H.R. 3741, 
the National Vaccine Injury Compensation Program Improvement 
Act of 2002. This bill does not address all of the flaws that I 
think exist in the program, but it's a good start.
    [The information referred to follows:]
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    Mr. Burton. Unfortunately, I've been told that the 
administration is opposed to the bill, and that's very 
disappointing to me. It's unfortunate that the pharmaceutical 
companies have so much influence over the Government of the 
United States. I just don't understand it.
    The Victims' Compensation Fund was set up for the express 
purpose of protecting the pharmaceutical companies and at the 
same time making sure that people who are injured from 
vaccinations and vaccination-related instances got compensation 
for that. And it was supposed to be nonadversarial. That was 
the intent of Congress; everybody was supposed to be better 
off. The pharmaceutical companies were supposed to be free from 
litigation, product liability litigation, and the victims were 
supposed to be compensated.
    And what we have now is, we have the vaccine companies 
urging legislators and people in the administration to oppose 
legislation that would make it easier for people to get 
compensation. And to me, that's just dead wrong.
    We took as our starting point a series of recommendations 
from an advisory committee. Some of them were good and some 
were not so good, and we took what we thought were the best 
recommendations and we built on those. We expanded on them 
because we want this program to be as effective as possible.
    But everything in this bill is bipartisan, everything is 
reasonable; and I can't see why the administration should 
oppose this. We doubled the statute of limitations from 3 to 6 
years, and the pharmaceutical companies don't want that. We 
increased the amount of death benefits from 250,000 to 300,000, 
and it hasn't been increased for more than a decade. Inflation 
alone would require that change, and they don't want that.
    We allow the program to pay interim attorneys' fees and 
costs. These provisions are of major importance for improving 
the ability of families and their lawyers to move these cases 
through the program fairly.
    Imagine how difficult it is for families when the 
Government can bring in any number of expert witnesses that 
they have, and an unlimited budget to do so, and the witnesses 
get paid right away; but families like the Zuhlkes and the 
Rogers have to wait 10 years to be reimbursed for the same 
    And we are not talking about super-wealthy families here. 
Thad Rogers is a factory worker. He works in a Michelin tire 
plant. Janet Zuhlke is a single mom, and she works part-time in 
a doctor's office.
    We have to level the playing field. Their lawyers have gone 
without payment while incurring tremendous expenses. And that 
is one of the reasons why people can't bring suits and try to 
get compensation for their injuries. They can't afford the 
lawyers, and the lawyers can't afford to work for nothing. Of 
course, that impacts their ability to represent their clients. 
All too often the Government is dragging out these cases for 5, 
6 years.
    And we have also included a one-time look-back provision. 
It allows for families who couldn't file claims because they 
missed the statute of limitations a 2-year period to file their 
claim. This provision has provoked stronger opposition than 
anything else in the bill; and I think that's really 
unfortunate because it would do so much to help families who 
just didn't know much about the program and didn't file on 
time, and those families really need help.
    I have a personal issue that bothers me, and it applies to 
thousands and thousands of people across this country. We have 
gone from 1 in 10,000 children that are autistic in America--
used to be 1 in 10,000; now it is more than 1 in 250. We have 
an absolute epidemic of autism.
    These other vaccination-related injuries are all 
important--all of them are important. But we have an absolute 
epidemic of autism. And these--1 in every 250 children are 
autistic, and those kids are going to grow up and many of them 
are going to be unable to go out in the work force and earn a 
living. They are going to be dependent on society and the 
Government for their existence.
    And what really bothers me is, we just don't have any 
foresight. The administration and the Government of this 
country ought to be thinking about these things and thinking 
about how to solve the problem now, not just compensation from 
the Vaccine Compensation Fund, but in making sure that these 
vaccines are tested and tested and tested again before they 
start using them on children. Many of these vaccines contain 
thimerosal or mercury. And there are aluminum and other 
substances in these that are preservatives that it is believed 
by many scientists around the world are causing these injuries.
    In addition to the Vaccine Compensation Program we are 
talking about today, the Government and the administration and 
health agencies need to get on with double-checking these 
vaccinations before they take place. And parents ought to be 
informed about the risks, and they ought to read the inserts 
before they give these kids these vaccinations.
    I mean, we're going to have to pay for all that. It just 
scares me to death when I think about the long-term financial 
impact that's going to have on the United States. I will be 
dead and gone when this happens. But the future generations and 
young folks in this audience are saying, how in the world are 
we going to pay for all this? Where are we going to put all 
these people?
    And as far as the Vaccine Injury Compensation Program, I 
got a letter from my daughter yesterday; and I try to help her 
as much as I can. But my grandson is autistic, and they have 
received tremendous bills to take care of my grandson 
Christian, who became autistic 2 days after getting vaccinated; 
and a lot of people have suffered the same kinds of problems.
    And they have gone bankrupt once, even though I helped 
them. And they are in dire straits again. And now we found out, 
just about 2, 3 months ago--I know you didn't want to be bored 
with my personal problems, but I think it's interesting to find 
out that Members of Congress have similar problems to what 
people across the country are having.
    My granddaughter received a vaccination when she was about 
6 months old for 6-month olds, for hepatitis B, and she quit 
breathing within just a matter of a few hours; and they rushed 
her to the hospital. And they saved her life, and she's been a 
very normal child, but now she's suffering from a mild form of 
epilepsy, and we wonder how that happened. There's nothing else 
that we can think of that could have caused it. There's no 
history in our family of anything like that.
    And these are things that our health agencies really need 
to take a hard look at. In addition to my grandson now being an 
undue burden on the family because of the medical expenses, now 
our granddaughter has to get special treatment, as well, for 
her condition. And I am not a poor fellow. I think I can afford 
to help them quite a bit, but I don't know how people across 
this country that are of average income, who don't have a lot 
of assets, can handle this.
    And the media has written about this in the past, but 
unfortunately it seems to be lost on the Government leaders. 
And it really, really bothers me not because of our family 
situation, because we'll figure out a way to get by, but 1 in 
250 kids is autistic.
    People aren't getting compensated for their medical 
expenses from these vaccine compensation funds. And the 
pharmaceutical companies are fighting it, and the 
administration--for what reason, I don't know--is opposed to 
some of these changes. And I just get totally frustrated.
    But I will tell you this, as long as I am active in 
Congress and chairman of the committee that is dealing with--
and I will be chairman of the committee, or a member of the 
committee that's dealing with this, we are going to continue to 
put pressure every place we can and try to illuminate the issue 
through the press and through the media to the American people. 
And 1 day--I am very hopeful and I believe we will get their 
    If nothing else happens, they are going to get the 
attention pretty quick when all these medical bills start 
coming in for all these kids across the country that are 
becoming autistic and other people that are suffering from 
other related vaccine injuries.
    Well, I got that off my chest. The record will be open 
until October 2 for the Members who are not here today, and I 
am sure that my colleagues will be looking at the record and 
looking at the testimony and entering their own statements in 
the record.
    And I want to say that Mr. Waxman and I have had a lot of 
differences, but he and I see eye to eye on this adjustment to 
the Vaccine Compensation Program.
    [The prepared statement of Hon. Dan Burton follows:]
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    Mr. Burton. With that, let me welcome our first panel. We 
are going to hear testimony from the first panel, which 
includes Ms. Janet Zuhlke, whom I mentioned earlier, and Ron 
    And I appreciate you coming here today to testify once 
again to bring us up to date on the situations we just talked 
about. So would you please rise and be sworn?
    [Witnesses sworn.]
    Mr. Burton. We will let Ms. Zuhlke, lovely lady, go first.


    Ms. Zuhlke. Again, good morning. Thank you for your words. 
My name is Janet Zuhlke and I am pleased to have been invited 
back here today. I gave testimony last year in November 
regarding my daughter Rachel Anne. I was invited here today to 
provide an update on her case through the National Vaccine 
Injury Compensation Program and to discuss my most recent 
experiences with the Life Care Planning Process.
    When I testified last year, I departed this room feeling 
that this committee had a better understanding of the 
difficulties, expenses and frustrations that families like mine 
have had to undergo in order to meet the criteria for this 
program; and you heard it not only from me, but also from other 
    Further, I believed the future process would become more 
expeditious, friendlier to the families, and that the outcome 
would be more favorable toward meeting the needs of the injured 
children. And I regret that my testimony today may be a 
disappointment for the committee.
    For reference, the key points of my testimony last year 
were the onerous costs associated with presenting a case, 
including in my Rachel's needs, the repetitive and expensive 
production of documents and radiologic films, the delays and 
extensions of deadlines caused mostly by the fact that, as 
petitioners, we are not given any interim costs to help us pay 
the expenses of this litigation and also caused by the DOJ 
repeatedly seeking delays to get updated medical records for 
their experts to review; the litigious and adversarial attitude 
of the DOJ throughout the entire process.
    A synopsis of the activities in my family's life since 
November is, one, although Rachel was declared eligible for 
compensation in July 2001 as a ``table injury victim,'' no 
compensation or interim payments have been awarded.
    Two, the Life Care Planning Process for my Rachel remains 
the area of contention. There is no agreement with the DOJ on 
the level of care and/or cost. The Special Master must now make 
a determination on compensating my family and for meeting 
Rachel's needs for the rest of her life. The past 10 months 
have been a continuation of the adversarial process that I 
described last year.
    As you'll recall, approximately 10 years ago--and as you 
stated, it will be 10 years at the end of this month that have 
been spent making the determination of Rachel's eligibility for 
compensation. All of her treating physicians were unanimous in 
their decision about causation. It was the DOJ whose experts 
were called in to read her medical records and to testify that 
Rachel's immunologists, neurologists, neurophthalmologists and 
pediatricians were all inaccurate. This debate went on for far 
too, too long.
    I need to explain to you about the Life Care Planning 
Process. It's been the focus of the post-determination activity 
to resolve this case. It is important to understand the role of 
the Life Care Planning Process used to formulate and agree upon 
its contents.
    An expert, referred to as a ``Life Care Planner,'' 
evaluates the medical status and prognosis of the victim. 
They're paid to project the level of medical care and living 
support needed for the individual's expected life span. They 
make these assessments by speaking directly to the attending 
physicians to clearly understand the future needs of the child. 
These needs include all medications, doctor visits, treatments, 
hospitalizations, mobility aids, special appliances and 
residency needs. The total cost of all life care needs 
determines the amount of money to be placed in trust for the 
    It's important to remember that once the amount is 
finalized, there's no renegotiating. It's a done deal. If the 
amount agreed upon was inadequate to meet Rachel's needs, we'd 
have no ability to go back to the program for additional funds.
    These Life Care Plans are provided--in my experience, have 
been provided separately to the Special Master. First, Rachel's 
Life Care Planner, which I will refer to now as an LCP, did her 
preliminary work-up. It was submitted to the Department of 
Justice for inspection.
    They, in turn, hired their LCP to oversee this plan and to 
submit their own with the necessary changes made that they were 
not in agreement with.
    Then Rachel's LCP goes through the process all over again 
to argue the point differences. That is referred to at this 
point as the final Life Care Plan.
    The plan is submitted to the DOJ to again look over and 
again bring in their LCP to do the same thing. Then at this 
point, both final plans are submitted to the Special Master for 
his review.
    You would anticipate that the two plans would have similar 
outcomes. In Rachel's case, the two were very different. It was 
brought to my attention that this program may be practiced in 
this manner to alleviate any issues or concerns that were not 
brought forth by the petitioner. If I had overlooked something 
with the LCP, too bad. Therefore the respondent would not have 
to acknowledge or address any outside speculative information. 
Again, I find this unacceptable in trying to meet the victim's 
    Without going into detail, let me just say that her 
condition has deteriorated since I was here in November. And if 
you have questions about it, I will be happy to elaborate on 
it. Again, I went over this with you last year and things 
aren't any better; they are worse.
    So if you have questions, I will be happy to answer them, 
but I am not going to go into them at this point.
    Mr. Burton. Thank you. We appreciate you coming back. And I 
might just say before we go to Mr. Homer that that is just 
indicative--this is just one example of thousands of cases and 
problems across this country that people are dealing with. And 
these are the ones that know about the program.
    Mr. Homer.
    Mr. Burton. Are you not finished? I'm sorry, I thought you 
were finished.
    Ms. Zuhlke. I am not a public speaker. I will try to be 
brief, but I do have other issues that I would like to address. 
Thank you, sir.
    The two main issues, as far as the DOJ is concerned 
referring to the compensation, are contesting and arguing about 
the appropriateness of a medicinal regime prescribed by her 
treating physicians to control further degradation of my 
daughter's health; and two, disagreement about the nature of 
Rachel's long-term care and the cost.
    I would like for all of you to understand that my 
daughter's life expectancy should be to reach the age of 25 or 
30. Again, she'll turn 18 on December 16 of this year and she's 
been ill since the age of 5.
    Last week, I flew into D.C. for the final hearing dates of 
September 4 and 5 to conclude this compensation effort for my 
child. It turned out that it had to be continued another day in 
length, until September 6, because of the arguments on the 
table concerning meeting Rachel's future needs.
    Concerning the first issue I just stated, about her 
receiving a medication not approved of by the DOJ, is a 
medication called IVIG. The DOJ litigated the appropriateness 
of the treatment, challenging the judgment of her physicians by 
hiring experts who have not lived with Rachel's case over the 
years and who were paid extensive fees by our Government to 
dispute Rachel's medications. It's proven itself to be 
beneficial to my daughter's care.
    An argument that the DOJ brought forth is that this 
medication is not a needed medicinal requirement for Rachel, 
and I believe that this issue is totally cost related. I think 
they are just not receptive to the cost of the medication and, 
therefore, unwilling to accept the medicinal benefits that it 
provides to my child.
    The other issue concerns placing Rachel in a life care 
facility that is specifically qualified to meet her medical 
needs. Rachel needs 24-hour care. Her placement will be 
expensive, not an argument; it is my goal to keep my daughter 
home for as long as is possible. I am aware of the fact that I 
can die in a car wreck, or something tomorrow, and God takes my 
life away; and in that, I need to make sure my daughter is 
taken care of.
    Eventually, the level of care that Rachel will need 
requires onsite medical staff that can resuscitate and 
administer emergency medications. The Government disagrees, 
believing that aide workers--and in the State of Florida, their 
health aides have no skills. They have nothing that--as an LPN 
or RN--they are not allowed to do anything other than call 911 
whenever an emergency occurs. This is not only unacceptable for 
my daughter; it raises the question in my heart, would these 
officials feel comfortable with this minimal care for their own 
    Also of concern to me is the fact that during last week's 
final hearing for compensation, the court reporter somehow 
inadvertently recorded over Rachel's testifying, treating 
physicians. It's not available to the Court to be transcribed. 
It's gone. Everything else for the Department of Justice and 
their arguments are available. The Special Master must now rely 
on his memory of the testimony given.
    As I stated, all other statements of testimony are 
preserved. And in a case of this magnitude and importance, how 
could such a monumental and catastrophic error occur?
    I'd like to take a moment to especially thank Special 
Master Hastings. He has made a strong effort to expedite this 
case for my daughter. From the time he took over Rachel's case, 
he was obviously committed to making a difference, to pushing 
this matter to a conclusion as expeditiously as possible; and I 
am very thankful for that, because I'm tired. I'm done. My 
daughter's dying, and I need help; and somebody's actually 
getting it. And I'm trying to be patient, and I know that--
again, I give him tremendous praise. He's making a wonderful 
effort in bringing closure for my family.
    I would like to say some things in general about the 
Vaccine Compensation Program. Now I've been told that Congress, 
when they passed this statute, intended for this to be a 
relatively simple, nonadversarial procedure. My experience is 
not at all consistent with that intention. As I saw the 
program, it is highly adversarial, and in my opinion, very 
    All of Rachel's treating doctors agreed she had a reaction 
to her vaccination. The Government went to extraordinary 
lengths to try to prove them wrong. I've been forced to borrow 
money to pay for voluminous medical records and radiology 
    It seemed like every time we got close to a hearing date, 
Rachel was hospitalized and the Government insisted on getting 
updated records, apparently hoping to find something that would 
help them disprove causation.
    My lawyer is Cliff Shoemaker, and he has stuck with me and 
my daughter through all of these years. He has received no pay 
for his time or reimbursement of his expenses for over 10 
years, and he's still not been paid. It will be months before 
he ever sees the first penny, while the Government experts are 
paid promptly upon billing the Government.
    Experts who testified for me and my family not only risked 
the wrath of the Government, but they had to wait years to be 
paid. One of the Government's experts last week in the recent 
2\1/2\ day hearing testified that he normally bills $500 an 
hour, but he's agreed to testify for the Government for a mere 
$200 an hour. It's obvious to me that there's a lot of value to 
be derived by these experts who agree to testify on behalf of 
the Government.
    And let me put it to you this way, no doctors are going to 
be applying to my lawyer for any grants. So when he asks them 
to defer their fees until the end of the case, they've got to 
be really dedicated to do the right thing.
    Mr. Chairman, I've had the opportunity to look at and 
discuss the provisions of H.R. 3741, a bill which you and 
Congressman Waxman have coauthored and which numerous other 
Congressmen and -women on both sides of the aisle have agreed 
to cosponsor; and as I understand it, this bill does three very 
important things.
    First, it changes the statute of limitations. While I was 
lucky enough to get to an attorney and file a claim within 3 
years of the onset of Rachel's symptoms, there are way too many 
parents who have not been so fortunate. And again, I strongly 
encourage Congress to remedy this problem.
    Second, H.R. 3741 allows for interim fees and costs. It is 
critical that the dedicated lawyers who are involved in these 
cases be compensated for their time and expenses on an ongoing 
basis. It is clearly not fair to ask parents like myself to pay 
these costs of litigation as well as our medical expenses. And 
it's not fair to ask lawyers who have dedicated their lives to 
this program to defer their fees and expenses. This is not a 
program where petitioners' lawyers are making a lot of money, 
but somebody is.
    Finally, H.R. 3741 makes it clear that this program is what 
Congress originally intended it to be, a remedial compensation 
program. It should not be considered a waiver of sovereign 
immunity where everything is narrowly construed in favor of the 
Government and against the petitioners.
    I would like to see this bill go further, but at least I 
have made this one statement. And thank you. I know I'm over my 
time. I am just thankful that you have given me the opportunity 
and the voice to speak from my heart concerning these issues. 
My daughter Rachel and I hope that what I have spoken about 
today will have meaning and will help the families that will 
follow behind me. Thank you.
    [The prepared statement of Ms. Zuhlke follows:]
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    Mr. Burton. Thank you, Ms. Zuhlke, and we will have some 
questions for you in a minute. And as one who has had that kind 
of a problem in our family, not to the degree that you have, I 
understand; and we will continue to fight to try to get some 
positive changes.
    Mr. Homer.
    Mr. Homer. Good morning, Mr. Chairman and others.
    Vaccines are an important part of our Nation's health 
policy. In 1986, vaccine manufacturers threatened to stop 
manufacturing vaccines because of civil lawsuits against them. 
In response to the crisis, Congress established the vaccine 
    Congress created this program for two reasons. One was to 
protect the vaccine manufacturers from civil lawsuits so they 
would continue to manufacture vaccines. Congress accomplished 
this goal by requiring that all new claims for vaccine-related 
injuries be filed in the vaccine program. The second reason was 
to compensate individuals who could show they were injured by 
    The vaccine program was Congress's first real attempt at 
tort reform. It created a new forum to resolve vaccine claims. 
However, Congress was also reluctant to abrogate the State's 
rights of injured persons. Therefore, Congress decided if a 
person's claim for compensation was denied in the vaccine 
program, or if the reward was too small, the individual could 
opt to reject the decision of the vaccine program and proceed 
as before with traditional litigation against a manufacturer.
    Obviously, Congress did not want this to happen. It wanted 
all claims to be resolved in the vaccine program. Therefore, 
Congress tried to make the program extremely attractive to 
claimants. It tried to make the program expeditious and fair. 
It tried to remove the difficult determinations of causation 
and negligence. It tried to create a no-fault compensation 
program under which awards could be made to vaccine-injured 
persons quickly, easily and with generosity.
    Indeed, Congress fully expected that the speed of the 
compensation program, the low transaction costs, the no-fault 
nature and the relative certainty and generosity of the 
program's awards would divert a significant number of potential 
plaintiffs from litigation and compensate many persons 
presently without a remedy under current tort law.
    I believe many of the goals of Congress have been 
accomplished. I believe America can be proud of the vaccine 
program. For example, I am aware of no cases where a person has 
lost a claim in the vaccine program, then prevailed against a 
manufacturer in a civil lawsuit. I am aware of no case where a 
person has rejected a vaccine program award as too small, then 
obtained more money in a civil lawsuit against a manufacturer.
    To my knowledge, there continues to be a sufficient supply 
of vaccines. In addition, a far greater number of vaccine-
injured persons are now receiving compensation. In my opinion, 
because of the creation of the program, hundreds of persons 
previously without a civil tort remedy, persons who would never 
have previously been compensated, have received substantial 
benefits from the program. This is good. It is consistent with 
congressional intent.
    Are there serious problems with the program? Yes, there are 
several. I wish to briefly discuss two problems, two problems 
which I see as the most significant and the most dangerous.
    In 1991, over 11 years ago, my client, Diane Rogers, was 
devastated by a tetanus vaccine. It caused her an MS-like 
illness which has left her bedridden. She filed a claim in the 
vaccine program in 1994, over 8 years ago.
    Her treating doctors concluded her injuries were likely due 
to her tetanus vaccine. In addition, several expert witnesses 
testified that Diane's illness was likely caused by her tetanus 
vaccine. A Special Master determined Diane's injuries were due 
to the vaccine. A judge at the Federal claims court has agreed.
    However, Diane has not received any compensation. In fact, 
11 years after her injury and 8 years after she filed the 
claim, the end is not in sight. Given her health, she may not 
live to see the end.
    Why has it taken so long for the program to resolve her 
claim? Although the reasons are many, I would like to highlight 
two. First, the Department of Health and Human Services and the 
expert witnesses it chooses to evaluate claims frequently 
requires scientific certainty before it will concede an injury 
has been caused by a vaccine. This was certainly not the 
intention of Congress. All Congress required is a showing, 
based on good science, that the vaccine is the likely cause of 
the injury.
    Second, since proof of scientific certainty in these cases 
is almost never available, any expert testimony offered by any 
expert from either side is subject to valid attack. 
Accordingly, the Secretary, with its requirement for scientific 
certainty, can and does make proceedings in the vaccine program 
as adversarial as any civil, traditional, tort litigation.
    Congress never intended for this to happen. It intended for 
claims to be resolved in the program with a showing that the 
vaccine was the likely cause of the injury, not the certain 
cause of the injury. In Diane's case, the Secretary has 
required scientific certainty. Since she has been unable to 
prove her case with scientific certainty, Diane's case has been 
as adversarial as any in the history of the program.
    The Secretary initially denied Diane's claim. When after 
two evidentiary hearings, the Special Master found in favor of 
Diane, the Secretary requested that the Special Master 
reconsider her opinion. When the Court of Claims agreed with 
the Special Master, the Secretary asked the judge to reconsider 
his opinion. When the judge declined to do so, the Secretary 
appealed the case to the Federal Circuit or at least noticed to 
the Federal Circuit that they will appeal.
    All this fighting in a case where the Special Master called 
the evidence overwhelming, where Diane's treating doctors and 
experts agreed that the vaccine caused the injury, where the 
Secretary's experts who were unable to even offer some other 
likely cause of the injury.
    To date, the program's been a success. However, the 
Secretary's requirement for scientific certainty and the 
resultant adversarial nature of the Secretary's defenses in the 
program do not bode well for the program's future. Success may 
soon evolve into failure.
    Recently, hundreds of cases have been filed in the program 
alleging vaccine-caused autism. Countless civil attorneys 
across the Nation now point to the high level of proof required 
in the program. They point to the adversarial nature of the 
program. They tell their clients they can leave this program 
after 240 days. For the first time, the success of the program 
is in jeopardy if, in fact, these clients go on and pursue 
civil litigation.
    In my opinion, a return to the old days would be a 
disaster. To prevent this, Diane and others like her must be 
compensated. The program must be fair, but expeditious and 
generous as Congress intended.
    The program is not about scientific truth. It's about 
compensating persons who are likely injured by a vaccine. It's 
about the resolution of claims, not perpetual litigation and 
appeals. It's about preserving the vaccine supply so we can 
continue to protect our children from devastating disease. It's 
about working together to find an acceptable balance for the 
competing needs of our open society.
    Thank you, Mr. Chairman.
    [The prepared statement of Mr. Homer follows:]
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    Mr. Burton. We understand we have a video. Since they 
couldn't be here, we would like to see that now.
    [Videotape shown.]
    Mr. Burton. I wish everybody in the Congress could hear 
that kind of testimony. I think it would have a positive 
    Mr. Homer, let me just start off by saying that you said 
that a lot of lawyers in the case of the autism epidemic are 
now filing, or getting together and filing, a joint suit 
against the Government, which could lead to a destruction of 
the program.
    Mr. Homer. It's a very likely scenario, sir.
    Mr. Burton. I just want to say this. I am a Congressman and 
I helped create the program--and I hope the Justice Department 
and health agencies hear this--but if destruction of the 
program is what it takes to get these peoples' attention, then 
I will testify in open court on these cases. I mean, I cannot 
understand why the Justice Department appeals and appeals and 
appeals these cases when they aren't doctors and they are not 
experts, and they go on and on and on; and you've got these 
people who are suffering these huge medical expenses, and their 
wives and their kids are suffering and they're going bankrupt. 
And the Government creates this fund to help solve the problem, 
to help protect the pharmaceutical companies, and it just 
doesn't work for so many of these people. Granted, a lot of 
people have been helped, but it's not supposed to be as 
adversarial as it is.
    And I think the lady in the bed, who was making that 
comment there, Ms. Rogers, I think she makes a very good point. 
If it is adjudged that somebody should get compensation from 
the fund and the Justice Department and our health agencies 
decide to appeal it, during the appeal process, they ought to 
be compensated. And the lawyers' fees ought to be paid, because 
how else are they going to get help?
    I have a personal experience with this, and I am talking to 
everybody now, especially the people who are going to be on the 
next panel. My son-in-law and my daughter have filed bankruptcy 
once. They can't do it again for 7 years. They've got medical 
bills out the kazoo for my grandson, who's autistic, and now 
they've got them for my granddaughter. And I'm going to help 
them, but a lot of these people can't do that.
    What do they do? What do they do? What is this fund all 
    And so I really mean this, and I'll tell the lawyers who 
are paying attention to this, if you need somebody to testify 
at the case, especially in the autism cases, if you need 
somebody to testify about the shortcomings of this program and 
why this program needs to be corrected--and if the Congress of 
the United States and the administration will not correct it, 
and we have legislation to do that, then I think these civil 
suits should be pursued. And if it causes the program to fall 
apart and for us to have to revisit it after it falls apart, 
then so be it. These people should not have to suffer like 
    You've got 1 out of 250 kids in the country that are 
autistic. It's a 40fold epidemic, and we're not doing anything 
about it with an awful lot of these cases.
    And a lot of these people haven't found out about it until 
the time has run out on them being able to file a suit, file a 
case. And the look-back provision makes some sense, but the 
pharmaceutical companies are against it and they swing a big 
axe in this town.
    Well, let me just ask a few questions, Ms. Zuhlke. How many 
medications does Rachel receive in any given month?
    Ms. Zuhlke. Well, sir, on a daily basis, she's receiving 
seven oral medications. I give her injections every other night 
of another medication. And she is currently going into the 
hospital for 5 days every month for the infusion of the IVIG.
    Mr. Burton. So she gets an IV, as well, for 5 days?
    Ms. Zuhlke. Yes, sir.
    Mr. Burton. How do you pay for all this?
    Ms. Zuhlke. I look at it as making a car payment or 
anything else, sir.
    Mr. Burton. Are you in debt?
    Ms. Zuhlke. Yes.
    Mr. Burton. Can you tell us how much it has put you in 
    Ms. Zuhlke. At this point I still do have insurance on my 
Rachel, which is a blessing, but I am thousands of dollars in 
debt to Shands Hospital, to Wuesthoff Hospital, which is our 
local facility, and that's where I am able to take her every 
    I've got it worked out now that instead of having to take 
her to Shands for these infusions, I'm able to have this taken 
care of through her pediatrician, Dr. Rick O'Hern, locally. 
That way I can spend the night with my daughter and get up and 
go to work in the morning. Otherwise, I'd be missing work, 
because Shands is 3 hours from my home. So I don't have loss of 
income anymore, which is great.
    Mr. Burton. Since you were last here, have you seen any 
difference in the way the Government lawyers have handled the 
case? Have they tried to be more sympathetic or more helpful?
    Ms. Zuhlke. No, not at all, except with the Special Master 
who is in charge of this case; I think he has done an 
exceptional job.
    I did have issues before, which I will not go into today; 
and again not with this individual. The adversarial process is 
still an ongoing issue. As I stated before, the Life Care 
Planning Process has been a back and forth; we can't agree on 
anything about the care, on the costs of treatments. It's just 
    And it's been months and months of going back and forth 
with these life care planners in trying to formulate, you know, 
to meet Rachel's needs.
    Mr. Burton. But your daughter's injury was what they call a 
table injury.
    Ms. Zuhlke. That's correct.
    Mr. Burton. And so it should have been a very simple 
    Ms. Zuhlke. You would think so, wouldn't you, sir?
    Mr. Burton. As complex as your daughter's case is, and as 
long as you have been dealing with these particular doctors, do 
you think Rachel's doctors would have prescribed an expensive 
IV medication unless she absolutely needed it?
    Ms. Zuhlke. Absolutely not. And I as a parent--a point that 
was made to me during last week's hearing with the DOJ is, you 
know, how could you subject to putting your daughter into the 
hospital for 5 days every month? I mean, how cruel.
    Well, excuse me. It is what is necessary to do for my 
child. I feel that strongly, or I would not subject my child.
    Mr. Burton. But your doctor has said that that was what she 
    Ms. Zuhlke. All of them. All of them.
    Mr. Burton. And the Justice Department inferred that you 
were being cruel because you were doing that?
    Ms. Zuhlke. That's absolutely correct.
    Mr. Burton. But you were following doctor's orders.
    Ms. Zuhlke. OK.
    Mr. Burton. OK.
    Dr. Weldon.
    Dr. Weldon. The IVIG is very expensive.
    Ms. Zuhlke. Yes, it is.
    Dr. Weldon. And that is the bone of contention between you 
and the Justice Department.
    Ms. Zuhlke. Apparently, that's correct. That's my belief.
    Dr. Weldon. Who prescribed the IVIG initially?
    Ms. Zuhlke. Initially it would have been her 
neuroophthalmologist, which was Dr. John Guy at the University 
of Florida Shands Hospital. And the reason that it was 
prescribed is that Rachel has a condition referred to as optic 
neuritis. She has been blind twice. And with the IVIG treatment 
in conjunction with another medication called IV solumedrol, 
which is a high-dose steroid, it has reduced the inflammatory 
process to the optic nerve, which has restored her sight. She 
is again in the throes of optic neuritis, and the IVIG is being 
administered, and again, once--once the optic nerve is 
diseased, there is retardation. There is no regeneration, if 
you will, at all. There is scarring.
    Dr. Weldon. I'm familiar with what optic neuritis is.
    Ms. Zuhlke. OK. Yes, you're a medical doctor.
    Dr. Weldon. You remember, I'm a medical doctor.
    Ms. Zuhlke. I apologize.
    Dr. Weldon. I know Dr. O'Hern. And, by the way, thank you 
for coming again.
    The IVIG, is that considered experimental?
    Ms. Zuhlke. No, sir, Not as far as Rachel's physicians are 
concerned. If you want to label it as experimental, it would be 
in trying to find the appropriate aggressive medications to 
work for my daughter.
    Dr. Weldon. Have you--how long have they been giving the 
IVIG for?
    Ms. Zuhlke. She has been receiving it for almost a year 
    Dr. Weldon. And how long do they anticipate that she will 
continue to need that?
    Ms. Zuhlke. There is no answer to that. And I will be the 
first to tell you that Rachel had been on it previously--this 
was over 2 years ago--and she started failing neurologically, 
and by that I mean not being able to go to the bathroom, not 
being able to walk, not being able to speak, grand mal 
seizures, etc. We switched over to another medication called 
Avonex, which is something which I had to inject; it was an I M 
injection for my daughter. She was on that for 1 year. She 
started to feel neurologically again, just the same issues.
    Then we went over to a drug called Betaseron, which is one 
that she is on now which is a ``subcu'' injection that I give 
her every other night. The Betaseron was working very well for 
the child, but now again, with the involvement of the optic 
neuritis, the IVIG was reintroduced as of Tuesday. I took her 
back to Shands to see Dr. Bahti, who works in conjunction with 
Dr. Guy, neuroopthalmology. The child's vision is maintaining 
itself, the stability, if you will. Her vision has improved, 
and 3 months ago when we were there, it was at a 2,200. 
Previously it had been 2,300 in one eye, 2,200 in the other. 
Three months ago it was 2,200 again. When I took her back last 
Tuesday, the vision is stable. It's at 2,200 in both eyes. 
That's phenomenal. And, again, the treatment is the IVIG.
    Dr. Weldon. Have you seen--just as a parent, not based on 
the medical evaluations and what the doctors are telling you--a 
response to these IVIG?
    Ms. Zuhlke. Absolutely. Yes, I have.
    Dr. Weldon. What have you be able to perceive as the 
benefits of it?
    Ms. Zuhlke. One thing--and again, I don't know how to 
explain this to the committee, but a lightness in my daughter's 
spirit. She seems to be a happier person. She is able to walk 
better. She is able to converse and communicate more. Her life 
functioning skills improve, and I'm not the only one that 
notices it. And besides the physicians, when I take her into 
the hospital every month, the nurses are aware of it and this 
last go-around made a comment about, you know, it's amazing 
when she comes in, within 2 to 3 days you can see a difference 
in Rachel. And by the time we come back in for the monthly 
infusion to be reinstated, you can see the deterioration in the 
    So there is absolutely a change for the better for my 
    Dr. Weldon. And I just want to clarify. The attorneys for 
the Federal Government accused you of being cruel to your 
daughter by your giving her this treatment?
    Ms. Zuhlke. Yeah. Yes, sir.
    Dr. Weldon. What exactly did they say?
    Ms. Zuhlke. Well, there was--again, you know, how can you 
subject to child to the 5-day course and this? And, again, this 
was coming from the expert that has been hired by the DOJ that 
was in the presence of the court during that time that--it was 
just, you know, how can you do this? And you are not seeing--
what he--he kept referring to risk and benefit factors, and, 
again, you know, markers that could be obtained that they are 
not seeing, etc.
    So again, sir, I can't give it to you verbatim, but I am 
telling you the truth. And the transcriptions should be 
available to you if you would like to look them over.
    Dr. Weldon. Mr. Chairman, we have described this as 
adversarial. I would describe it as abusive. I wouldn't 
describe it as adversarial. I mean, this is--you know, I know 
some of the doctors involved with her care. These are respected 
physicians in the community, these are not crackpot physicians 
that are looked on with disrepute. I mean, Dr. O'Hern is one of 
the most well-respected pediatricians in the entire country. 
And that's abusive. I don't know how else to describe it.
    I mean, this woman is not a physician, and she is following 
the directions. She is going to Shands Hospital. Shands 
Hospital is the hospital attached to the University of Florida. 
This is one of the most prestigious research institutions in 
the entire State of Florida, if not the Southeast. It receives 
a tremendous amount of NIH granting. There are--some of the top 
brains in the country are at this institution, and these people 
are prescribing this. And we have attorneys for the Justice 
Department describing this as child abuse?
    Mr. Chairman, this is totally unacceptable, and I am really 
looking forward to the testimony from the Justice Department 
because I am in shock. I don't know what else to say. I yield 
    Mr. Burton. Thank you, Dr. Weldon.
    Judge Duncan.
    Mr. Duncan. Well, thank you very much, Mr. Chairman. And I 
want you to know I appreciate your continuing to bulldog this 
issue and to do everything you can in regard to the problems 
that have occurred. And I appreciate the work that Dr. Weldon 
has done.
    As I have mentioned before in here, I knew nothing about 
this problem until a woman whose son had received a D P T shot 
that went bad, a perfectly healthy boy of approximately a year 
old, and at the time she came to see me, he was 21 years old 
and weighed 22 pounds and had continual convulsions and 
projectile vomiting and all kinds of horrible problems. And 
then a couple years ago, I had another family in my district 
who brought me their 6-year-old son who had a similar 
occurrence and having terrible problems. And so I've been very 
interested in the testimony that we have heard at these 
    And, Mrs. Zuhlke, I can say this: As a lawyer I handled a 
wide variety of cases, and then for the last 7--for 7\1/2\ 
years before I came to the Congress, I was a circuit court 
judge in Tennessee, a State trial judge, and I can tell you I 
think it is totally ridiculous that you have had an injury that 
occurred 12 years ago and a petition that was filed 10 years 
ago, and still, you still haven't received compensation after 
all this time. And I do know that most government lawyers don't 
have nearly as many cases to handle as lawyers in private 
practice, and so they often try to drag things out, but this is 
pitiful. This is terrible to drag these kinds of cases out all 
these years.
    Mr. Homer said he didn't think his client was--I think you 
said you didn't know whether your client was going to live to 
see the conclusion of this case.
    And when you talk about scientific certainty, in the face 
of overwhelming evidence--you know, there are very few things 
in this life that can be proven to scientific certainty. I can 
give you all kinds of examples of that. But you can find many 
leading scientists that tell you with great certainty that 
global warming is occurring, and then you can find other 
leading scientists who say just the opposite. And there is very 
few significant types of cases that could be proven to a 
scientific certainty, but the evidence is overwhelming, that 
should be--that should be enough.
    But, Mrs. Zuhlke, since you last testified before our 
committee, how have you be treated by the opposing lawyers? 
What's been their reaction?
    Ms. Zuhlke. Well, sir, again, I haven't seen any change in 
how I've been treated, which is, again, as I stated when I was 
here before, I believed that there would be changes. And again, 
I'll consider this because I'm here, because where I am, that 
this is considered a high-profile case possibly. So I would 
think that people would have really been a little more helpful, 
nonadversarial, and that is not what has occurred, and I was 
shocked by that. I still am.
    Again, the only thing that I can say is that I have someone 
involved now--meaning the special master--that has proven 
himself to me at this point to moving things along. I'm hoping 
to hear within the next couple of weeks that compensation will 
be forthcoming. I am afraid that the DOJ will appeal it. It 
would not surprise me. I'm ready for it.
    Mr. Duncan. Well, I hope that they don't--that you don't 
suffer repercussions because of your testimony here, although I 
wouldn't be surprised.
    If there was--if there was one change you could make in 
this program, what would it be? What do you think?
    Ms. Zuhlke. One change. That's very difficult, sir. Again, 
the money issue, outstanding medical bills, and, again, no sort 
of compensation, no interim help of any kind. It's very, very 
difficult. It would be--I would just be grateful to have been 
financially helped at this point.
    I think that the biggest problem for me is the adversarial 
issues, where Rachel's physicians are all unanimous in what 
they think; and here I have individuals that don't know my 
daughter, are not treating her, they are reading something on a 
piece of paper and making judgments and assessments on their 
own. And I just--I find that unacceptable. I mean, if there 
were issues to begin with, you know, nonagreement again between 
the physicians involved, you know, then speculation of it's--
that this was not an accurate assessment about causation, I 
could understand that. But for this blatant, long-term, here we 
go over and over and over again, that's----
    Mr. Duncan. My time has expired, so let me just ask very 
quickly. Mr. Homer, you said that you knew of no cases that--in 
which somebody had prevailed after they had been denied 
compensation under the program. Are there many cases that have 
been filed after somebody's been denied? I would assume that 
there would be--after somebody fights through this program for 
years, I would assume that not many people can afford to file 
these types of cases. How many cases have there been of this 
    Mr. Homer. How many cases?
    Mr. Duncan. How many cases have there been where somebody's 
been denied, where they have gone all through the program, and 
then they filed a suit in Federal court? Do you have any rough 
    Mr. Homer. I don't, sir. We don't handle civil litigation 
postprogram. But I am aware of cases out there; I'm not aware 
of many cases.
    Mr. Duncan. I think they would be extremely rare just 
because of the money and the time involved. Almost nobody 
besides the government has deep pockets enough to keep fighting 
this for years and years and years.
    All right. Thank you, Mr. Chairman.
    Mr. Burton. I think we will ask just a few more questions. 
I have some more questions I would like to ask, and if you 
would like to ask a few more, we will be happy to grant that.
    Let me ask one more question, Ms. Zuhlke. We have a 2-year 
look-back provision. This means that if a family whose child 
was injured by a vaccine after 1988 did not know about the 
program and they missed a filing deadline, they would get 2 
years in which to file a claim. Now, the Justice Department 
opposes this. I'm talking about our legislation now. Here is 
one of their reasons. ``The provision would have the 
inequitable effect of penalizing those who pursued their rights 
in a timely fashion and promptly adjudicated their claims.''
    Now, you pursued your rights in a timely fashion, and you 
promptly adjudicated your claim. How would you feel about 
giving families who missed the statute of limitations a 2-year 
look-back or a short period of time to file a claim? Do you 
think that would be unfair to you?
    Ms. Zuhlke. No, sir. I--again, in addressing that, I knew 
within 6 hours of my daughter's immunization that there was a 
problem. So--and again, it was her pediatrician that shared 
with me--I didn't even know that this program was available to 
    Mr. Burton. But there are certain families that may not be 
aware of the program and may have a problem that occurs later 
    Ms. Zuhlke. I think the statute of limitations should be 
    Mr. Burton. And you don't think it would be unfair to you?
    Ms. Zuhlke. No, sir.
    Mr. Burton. OK. Thank you.
    Let me ask you a couple questions, Mr. Homer.
    Mr. Homer. Yes, sir.
    Mr. Burton. You have litigated a lot of these cases, 
haven't you?
    Mr. Homer. Yes. I would say I have brought to conclusion 
anywhere from 250 to 300 cases, and presently my law firm has 
about 300 active cases.
    Mr. Burton. And you have been fairly satisfied with the 
result of the program?
    Mr. Homer. Yes. I think that's a fair statement. Yes.
    Mr. Burton. But you do see some inequities and some 
problems with the program, as in the case of the Rogers.
    Mr. Homer. Yes, sir.
    Mr. Burton. Tell me about these class-action suits that are 
being filed like by the families of autistic children. And 
there's thousands of them across the country that are going to 
be getting together to file this class-action suit.
    Mr. Homer. Yes, sir.
    Mr. Burton. What do you think would happen if they 
prevailed in court? What would that do to the pharmaceutical 
    Mr. Homer. I think it would be devastating. I think it 
would be very similar to what happened to the asbestos 
companies that eventually made many of them go bankrupt.
    Mr. Burton. And what do you think that would do to the 
companies that are providing very important vaccines in this 
country if they went belly up?
    Mr. Homer. Well, then we are back to what I refer to as the 
old days, where vaccine manufacturers can no longer produce 
vaccines which----
    Mr. Burton. Because of the risk.
    Mr. Homer. Yes.
    Mr. Burton. So it could lead--at a time when we have a war 
going on and we need to have vaccines for smallpox and other 
things, it could lead to a very serious shortfall if some of 
these companies down the road went bankrupt because these 
lawsuits prevailed and were upheld in an appeal.
    Mr. Homer. It's a reality. Yes.
    Mr. Burton. That's why I don't understand why our 
government is so short-sighted, both our health agencies and 
our Justice Department, because if they don't realistically 
look at these things--I mean, maybe you would disagree, and you 
are welcome to express yourself. It seems to me that they would 
try to be realistic and look at these cases, and try to 
adjudicate them as quickly as possible so that they don't have 
this kind of a problem with class-action lawsuits that might 
prevail, because I, quite frankly, think if this goes before a 
court, and the overwhelming evidence is that, you know, 
Thimerosal and mercury and--mercury and vaccines and other 
substances have led to a lot of these cases, I think there is 
scientific evidence from Europe and elsewhere that this has 
been a problem, I think that courts will rule in their favor, 
and if they do and they appeal it--it may take some time before 
the appeals process takes place, but ultimately it appears to 
me that there is a very good likelihood that the pharmaceutical 
companies could take it on the chin, and this would have a 
reverberating bad impact over the entire country, don't you 
    Mr. Homer. Yes, I agree. And I think, up to this point in 
time, that was not so much of a concern, but now recently, with 
the possibility of vaccines causing autism, you have a lot of 
interested civil litigators all throughout the country 
interested in this, and they see that not--they are looking at 
the program as more of an obstacle. And what will happen if 
they--you will see that many of these civil litigators are not 
filing in the program to begin with, which could present a 
problem ultimately, but if they are forced to--and they will be 
by the State courts and Federal courts, they will file in the 
program--if it's as adversarial--if it's as difficult to put a 
case through this program as it is civilly, then why go through 
the program? Just put it in, pull it out after 240 days, and 
let's get a class action going. That is what's going on out 
    Mr. Burton. Well, you are a trial lawyer, are you not?
    Mr. Homer. My practice is actually specifically with the 
vaccine program.
    Mr. Burton. Do you do any trial work?
    Mr. Homer. Not outside the vaccine program.
    Mr. Burton. Well, as a lawyer who has dealt with this, what 
do you think the probability is that a class-action suit like 
this would be successful?
    Mr. Homer. Well, actually I'm part of an alliance with--and 
part of that alliance, there are civil litigators involved, and 
we are actually working with them attempting to put these cases 
through the program, specifically the autism cases. And if the 
result through the program is not acceptable, they're--you 
know, they are ready to bring these civilly.
    Mr. Burton. I know. What do you think the prospect is of 
them being successful in court and making their case?
    Mr. Homer. I think if they brought a case today, they would 
not be successful, but I think with the ongoing studies and a 
year, 2 years' time, I think there will be enough evidence 
where these civil litigators will be successful in courts.
    Mr. Burton. So you think short term, maybe not, but you 
think long term they will be successful?
    Mr. Homer. Yes, sir.
    Mr. Burton. And the resulting costs to the pharmaceutical 
industry in the country would be huge?
    Mr. Homer. Absolutely.
    Mr. Burton. OK. As I understand it, your contention is that 
Mrs. Rogers had a genetic predisposition to multiple sclerosis, 
and that the tetanus shot triggered the illness; is that 
    Mr. Homer. Yes.
    Mr. Burton. Is it fair to say that this was a fairly 
complicated case, and that it was a pretty close call for the 
special master?
    Mr. Homer. Yes. I think the science is very complicated, 
especially at the first hearing in 1997. The second hearing, 
more--new evidence was available. I think it clarified some of 
the medical issues. But, yes, I think it was a very complicated 
case medically.
    Mr. Burton. And you think the special master has been fair 
in this case?
    Mr. Homer. Oh, yes. I think she has done a very good job.
    Mr. Burton. In August 2001, the Rogers family was awarded 
about $1 million, and this came about a year after the special 
master granted them entitlement. About 1 month later the 
Justice Department appealed to the Court of Federal Claims. The 
government isn't allowed to appeal until after the award is 
determined and accepted. Were you surprised that they appealed?
    Mr. Homer. I was surprised. And just to clarify that, she 
was awarded $1 million, and that would be a lump sum payment. 
There was additional--additionally, there is an annuity that 
would pay out about $100,000 a year for the rest of her life.
    But answering your question, was I surprised? I was 
surprised. I didn't see this case as--an issue in this case 
that, once resolved, would have a wide effect on other cases. 
If there was an issue here that, say, it was resolved in favor 
of the respondent, then that would affect, you know, 30, 40 
other cases. This was a very narrow issue. It only applies to 
the Rogers case: Diane Rogers; MS may be triggered by a tetanus 
vaccine. It's very fact-specific to each case. I don't think 
the special master was saying tetanus causes MS.
    Mr. Burton. I understand.
    Let me just ask one more question, and then I will yield to 
Dr. Weldon.
    There was an appeal.
    Mr. Homer. Um-hmm.
    Mr. Burton. The appeals court rejected the appeal, and the 
Justice Department then didn't say OK. They are going on with 
another appeal, correct?
    Mr. Homer. Yes. They have noticed the Federal circuit that 
they may--well, noticed the Federal circuit that an appeal may 
be filed, and I think that would be due, I think, the 27th of 
this month.
    Mr. Burton. Why do you think that's happening?
    Mr. Homer. You know, you try to look at these cases from 
the other side, and I truly am trying to look at it as a 
Department of Justice attorney or from employees of HHS, and I 
really can't get a grasp on it, what is the significant issue 
here in this particular case that is so important that it's 
going up to the circuit. I wish I could. Then it would be--I 
could explain that to my client.
    Mr. Burton. We will let them try to explain that in just a 
little bit.
    Dr. Weldon. We have a vote on after you conclude your 
questions. Unless you have more questions, I will excuse this 
panel, and we will get to the government people when we come 
    Dr. Weldon. I just have a few questions, Mr. Chairman.
    Mr. Burton. Sure.
    Dr. Weldon. Janet, I understand the special master in your 
case was asking that the case be resolved by the end of this 
month, which is the 10-year anniversary of filing the case.
    Ms. Zuhlke. That's correct.
    Dr. Weldon. Do you think that's likely, that you will be 
able to resolve this?
    Ms. Zuhlke. Yes, I do. And the reason I do is that during 
his closing statements at the hearing last week, he had even 
made a comment to me that apparently the court reporter and--
transcriptions that are made from those records normally would 
take 30 days. He told me he had specifically requested that it 
be done in 5 days, and that he wanted those materials set 
before him promptly, and that this was a top priority for him, 
and that he wanted very strongly to have closure to this before 
the 10th anniversary at the end of this month. So I believe his 
words, sir.
    Dr. Weldon. But as I understand it--and maybe, Mr. Homer, 
you can comment on this; you are a legal expert. The government 
can appeal to the circuit court even if the special master 
makes a decision here?
    Mr. Homer. Yes. The procedure is that the parties can 
appeal to, the first appeals, to the Court of Federal Claims. 
The next level is the Federal circuit. And then, of course, 
they can petition the Supreme Court for certiorari.
    Dr. Weldon. In the Rogers case would you say that the 
special master has been fairly conscientious in the way that 
she's handled this case?
    Mr. Homer. Yes, I think she has. I think she--in the sense 
that in 1997 she did write a decision in which she found 
against Mrs. Rogers, but, in all fairness, she entertained 
additional medical evidence and took additional testimony, and 
was, I think, large enough to say, hey, with this new evidence 
I have to reverse myself. And I think that's very difficult for 
any judge to do, but she did.
    Dr. Weldon. Now, I understand when she reconsidered and 
reversed herself, the Justice Department then asked her to 
reconsider her decision.
    Mr. Homer. Yes. As we asked her to reconsider her first 
decision, they asked her to reconsider her second.
    Dr. Weldon. Now, evidently she made some comments about the 
Justice Department lawyer--and this isn't the first time I've 
seen the special masters complain about the Justice Department 
lawyers. She said, this is not the first time respondent has 
attempted to circumvent the rules by introducing postdecision 
expert testimony. And she went on to say, in the strongest 
words possible, this court finds that the respondent's method 
of supplementing a closed record constitutes extremely bad 
practice, sets bad precedents, and is getting to be a bad 
habit. The court and the legal profession have vested interests 
in encouraging closure rather than imposing further delays and 
multiple responsive motions ad nauseam.
    Is this true?
    Mr. Homer. Well, I would like to clarify that. Remember, I 
don't think this is necessarily one particular trial attorney 
we are talking about. I don't know what the marching orders are 
from higher up for these trial attorneys about filing 
posthearing evidence.
    Dr. Weldon. Well, I'm just asking you, did the special 
master say those things I just quoted?
    Mr. Homer. Yes, sir.
    Dr. Weldon. Now, you have--this is going on 10 years. You 
said you have handled like 300 of these cases over the years.
    Mr. Homer. I've brought about 300 to conclusion. I have 
about 300 pending.
    Dr. Weldon. What's the average length of time that you 
spend on these cases?
    Mr. Homer. Interesting question, because recently I had 
to--for another hearing on attorney's fees, I had to prepare 
for that information. I took all the--we resolved 20 cases last 
year in my firm, so I used those 20 cases as--to format a 
response, and I found that on average, those 20 cases, from the 
time of filing until we receive our attorney's fee check, there 
was an average of 7 years. And nine of those cases we 
voluntarily dismissed. We got the medical records, we 
summarized them, we realized that there was not a case. There 
was a reasonable basis to investigate, but there was no reason 
to go further. Those cases took about 2 years. Cases that went 
through entitlement hearing and then went on to damages, it 
took an average of 7 years.
    Dr. Weldon. Mr. Chairman, I yield back.
    Mr. Burton. Let me just say, we will excuse this panel, and 
we will go to the government witnesses when we come back. We 
have to go vote on the floor right now. We should be back in 
about 15 minutes.
    But let me just say that I don't know how people of 
moderate income with a sick child can wait 7 years for that 
kind of a decision. It just--I just don't know how they do it.
    And with that, thank you both for testifying. I hope you 
can stick around to hear the government respond to some of the 
questions. We will be back in just a few questions.
    Mr. Burton. Could we have the government witnesses, Mr. 
Paul Harris, Sr., Deputy Associate Attorney General, U.S. 
Department of Justice, who is accompanied by Mr. John Euler; 
and Mr. William Hobson, Director of the Office of Special 
Programs at H H--Health Services Research Administration, 
Department of Health and Human Services, who is accompanied by 
Dr. Tom Balbier. So would you please all--are you all here? Is 
everybody here? OK. Would you please rise, and raise your right 
hand, please.
    [Witnesses sworn.]
    Do any of you have an opening statement you would like to 
make? Mr. Harris?


    Mr. Harris. Good morning, Mr. Chairman. I do have an 
opening statement.
    Chairman Burton, members of the committee, I want to thank 
you for the opportunity to appear before you today, and I am 
pleased to return on behalf of the administration to talk about 
the National Vaccine Injury Compensation Program.
    Over the past several years, this committee has proven its 
dedication to this important program, praising it for certain 
accomplishments and suggesting improvements where the program 
has not worked as effectively as possible.
    I would like to emphasize that we at the Department of 
Justice share your dedication to this program. In creating the 
program, Congress sought to encourage childhood vaccination by 
providing streamlined compensation in rare instances of vaccine 
injury. Fortunately, many more of our children are vaccinated 
today than were immunized a decade ago. Other positive results 
of the V I C P include the protection of the Nation's supply of 
life-saving vaccines and the research and development of new, 
better, and safer vaccines.
    We recognize that the success of the program is an integral 
part of the achievement of these interrelated goals and the 
overall success of our Nation's immunization program. We 
therefore take very seriously the program's effective 
    In my prior appearances before this committee, I provided 
lengthy written testimony. So as to limit my remarks this 
afternoon, I ask that my written statement for today's hearing 
as well as the written statements from the November 1, 2001, 
and December 12, 2001, hearings be incorporated into the record 
for this hearing.
    Mr. Burton. It will, without objection.
    Mr. Harris. Similarly, I ask that the Department's letter 
containing our detailed views of your bill, Mr. Chairman, H.R. 
3741, be included in the record as well.
    Mr. Burton. As well.
    Mr. Harris. In your letter of invitation, you requested 
that I address several areas of program administration with 
which you have expressed concern in the past. We, too, are 
concerned that there are examples of cases that have taken too 
long to resolve, that there are individuals who are displeased 
with the manner in which their case has been processed, and 
that some perceive the program as too adversarial. However, I 
think it is important to emphasize that these are the 
exceptions and not the rule. We continually look for ways to 
address concerns such as these.
    I believe that the Department of Justice and the Department 
of Health and Human Services have made improvements in the 
manner in which we process program cases. I would like to share 
with you examples of positive developments in the program.
    One means to lessen the potentially adversarial nature of 
the proceedings can be the use of settlement techniques such as 
alternative dispute resolution, or ADR, to resolve cases 
informally without the need for court hearings. I am pleased to 
report this afternoon that our reliance on ADR continues to 
grow. In the past 8 months alone, we have attempted ADR in 
almost as many cases as it was used in the first 10 years of 
the program's existence.
    The prompt processing of petitions continues to be a major 
focus of the program. I am pleased to report the success of an 
initiative initiated this year to resolve the program's oldest 
cases. In the beginning of the year, we identified all pending 
cases that had been filed in 1997 or earlier and redoubled our 
efforts to resolve these cases as quickly as possible. Eighty-
six cases fell into that category, but as of last week 67 
cases, or 78 percent of these cases, have been resolved on the 
    Of course, all program participants would like to see cases 
resolved in the shortest time possible; however, we are mindful 
that speedy and efficiency--speed and efficiency oftentimes may 
be inconsistent with the compensatory principles of the 
program. On balance, while prompt resolution is a worthy goal, 
the program tends to consider efforts to complete the record by 
allowing time to investigate and submit all relevant evidence 
to be of much greater importance. Yet even when the parties 
diligently work to provide the medical evidence and other 
documentation needed to substantiate a claim, some cases are 
extraordinarily complex and simply require great time and 
effort on the part of all parties and the court.
    In the most complicated cases, despite the best efforts of 
all parties, lengthy proceedings are unlikely to be eliminated. 
Mr. Chairman, you have identified two such cases involving the 
Zuhlke and Rogers families. Last year, when I appeared before 
this committee on November 1, 2001, I listened to both Mrs. 
Zuhlke and Mr. Rogers describe their experiences in this 
program. I have deep sympathy for the suffering that Rachel 
Zuhlke and Helen Rogers have experienced and the pain that 
their family members have also endured. One troubling aspect of 
each of these cases was that both involved complicated medical 
and legal issues, with the result that their cases had been 
pending for many years. Unfortunately, these cases remain 
pending, and thus, as before, I am unable to discuss specific 
details about either case. Nevertheless, I would like to 
describe what procedures have taken place in each case since 
last November to assure you and this committee that diligent 
efforts have been under way to resolve these issues.
    With regard to Mrs. Zuhlke's case, the special master 
issued a decision last July 2001 finding that Rachel suffered a 
vaccine injury. The process of determining the amount of 
compensation that Rachel should receive for her injury was 
initiated in August 2001. As of 2 weeks ago, a hearing was 
completed, and the case is now pending a decision from the 
special master. Over the past 14-month period that the parties 
worked to resolve the issues of compensation, efforts were 
concentrated on obtaining necessary documents through the 
issuance of subpoenas to physicians, filing exhibits with the 
court, including the all-important life care plans, and 
participating in monthly, then weekly, status conferences with 
the special master. The Zuhlkes filed their life care plan on 
March 29, 2002, setting forth the items they sought for 
Rachel's care, and the responsive life care plan was filed on 
behalf of the government approximately 3 months later on July 
3, 2002.
    To resolve the differences in the parties' opinions as to 
Rachel's future needs, a hearing was scheduled for September 4 
and 5, 2002. In the meantime, the parties participated in an 
ADR in July in an attempt to settle the matter sooner. 
Unfortunately, those efforts were not successful, and 6 weeks 
later the parties presented the issues to the special master 
for decision at a hearing during the first week of September. 
We now look forward to receiving a decision from the court.
    I agree that the Zuhlke case has taken too long, and I 
understand that this has been a frustrating experience for the 
Zuhlke family. Fortunately, the process is now nearly complete. 
While I unfortunately cannot share the specific reasons why 
this length of time was necessary in this particular case, I 
can state that our goal in such cases is to fashion 
compensation that is both appropriate and fair for the injured 
person's needs and is consistent with the requirements of the 
    The statute specifically identifies permissible types of 
compensation that may be awarded under the act. Included are 
reasonable projected unreimbursable expenses that, ``result 
from the vaccine injury'' and are, ``determined to be 
reasonably necessary for medical and other rehabilitative 
    Part of our mission includes a duty to support both the 
medical and fiscal integrity of this program. Each settlement 
in the program, whether it results from informal negotiation or 
ADR methods, is approached with this balance in mind.
    In evaluating requests for compensation, the Department 
relies heavily upon the expertise of doctors, nurses, and other 
rehabilitative experts to assess the claimant's needs and 
recommend items and services to meet those needs. Determining 
adequate and appropriate lifetime medical compensation takes 
time, and it is incumbent upon the parties to ensure that it is 
done properly the first time. Once the award is in place, it 
cannot be changed.
    I would also like to address the chronology of events that 
have occurred in the case involving Ms. Rogers, one of very few 
vaccine cases the Department has appealed. First, I would like 
to state that we are not insensitive to the personal tragedies 
that all claimants such as the Rogers family have endured, and 
understand that awaiting the outcome of the appeal process is 
frustrating. For these very reasons the government's decision 
to appeal in a particular case is exercised infrequently and 
with much caution. We generally appeal only those cases in 
which we believe an issue of law has been wrongly decided and 
is likely to negatively impact future cases.
    Some criticize that appeals cause unnecessary delay in 
reaching a final case disposition. Of course, appeals do add 
additional time. However, appellate rights, which are 
authorized by the statute, have predominantly been exercised by 
claimants, not the government. The government infrequently 
appeals program decisions of the special master and even more 
rarely to the U.S. Court of Appeals for the Federal Circuit.
    Moreover, the number of appeals filed by either party has 
decreased in recent years. For example, since January 2002, 
this year, claimants have filed appeals in five cases to the 
Court of Federal Claims; the government has appealed only one. 
In the Federal circuit, petitioners have filed two appeals this 
year, and the Department has filed one, and that one case is 
the case involving Mrs. Rogers. I would like to note that since 
1993, the Department has appealed only one other case to the 
Federal circuit, and that occurred 4 years ago in 1997.
    The specific procedures of Mrs. Rogers' case are as 
follows: In August 2001, the special master issued a decision 
awarding compensation to Ms. Rogers. For reasons I am prevented 
from discussing in detail, we filed a motion for review of this 
decision the following month, a procedure that is authorized by 
the act. Five months later, in February 2002, the reviewing 
judge remanded the case to the special master, sent the case 
back to the special master. As evident from the decision, the 
judge instructed the special master to provide additional 
information that established a basis for her conclusion that 
the vaccine administered to Ms. Rogers caused her injury.
    On April 24, 2002, the special master issued another 
decision confirming her conclusion, which the reviewing judge 
accepted on May 7, 2002, even though, as he noted, the special 
master's decision referenced evidence that was not contained in 
the evidentiary record.
    The Department sought reconsideration of the judge's order 
on May 21, 2002, which was denied on May 29, 2002. In 
accordance with the court's rules, a notice of appeal was filed 
at the Federal circuit on July 15, 2002. The government's brief 
setting forth the basis for the appeal is due September 27, 
2002, although a decision on whether to appeal has not been 
made by the Department at this time.
    We regret that an appeal prolongs a family's involvement in 
this case and, if the government's appeal is unsuccessful, will 
have the unintended affect of delaying delivery of 
compensation. We are mindful of the stress and difficulty 
associated with any sort of litigation. While we attempt to 
minimize these unfortunate consequences, there are occasions 
when, in our view, appeals must nevertheless be taken to defend 
the congressional mandate, preserve the integrity of the 
program, and promote its overall goals. Unfortunately, such is 
the case with Ms. Rogers' claim.
    I want to assure the committee again today that the 
Department is dedicated in its resolve to continually improve 
program operations. To help us meet this goal, we remain 
committed to working further with Congress, HHS, the court, and 
other interested groups such as the ACCV and petitioner's bar. 
And I will be pleased and happy to answer any questions that 
you may. And thank you.
    [The prepared statement of Mr. Harris follows:]
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    Mr. Burton. Mr. Hobson, do you have a statement?
    Mr. Hobson. Yes, Chairman Burton.
    Mr. Burton. Would you pull the mike a little closer, sir, 
and turn it on.
    Mr. Hobson. Yes.
    Mr. Hobson. Chairman Burton, my name is William Hobson. I 
was recently assigned to be the Director of the Office of 
Special Programs in the Health Resources and Services 
Administration. Currently I have been serving in that position 
for a little less than 2 months. Joining me today is Mr. Tom 
Balbier, who has worked with the Vaccine Injury Compensation 
Program Division of our office for approximately 11 years.
    I am happy to appear before you today to discuss the 
National Vaccine Injury Compensation Program. As you know, the 
program is administered jointly by the Departments of Health 
and Human Services, Department of Justice, and the U.S. Court 
of Federal Claims. As the Director of the Office of Special 
Programs at HHS's Health Resources and Services Administration, 
I am very eager to work with you to ensure that the program is 
both expeditious and fair and operates as Congress intended.
    In your September 11th letter of invitation, you asked that 
I be prepared to discuss two things: The cases that were 
presented by the previous witnesses, as well as the National 
Vaccine Injury Compensation Improvement Act of 2002, H.R. 3741.
    To address your first request, because these cases are 
currently pending in Federal court, I cannot discuss them 
specifically, but, as you suggested in your letter, I can 
comment generally.
    On the human level I express my very deepest sympathy to 
anyone who suffered a painful and debilitating injury and to 
the people who love and who are responsible for caring for 
those injured individuals. Such occurrences are surely among 
the most difficult that any of us has to face.
    At the level of someone who works with the program, I know 
the diligence and dedication of my coworkers who have been 
charged with carrying out the National Vaccine Injury 
Compensation Program as established by Public Law 99660. Our 
job at HHS is to do the best we can operating within the 
program as established by law. Each case is handled 
individually; each case is subject to the same scrutiny.
    To address your second request, I know that you, Chairman 
Burton, and Ranking Minority Member Waxman have both been 
working to modify and improve the National Vaccine Injury 
Compensation Program through H.R. 3741, which was introduced in 
February of this year. There are many provisions in the 
legislation that the Department of Health and Human Services 
supports. Many of them also have the support of the Advisory 
Commission on Childhood Vaccines. I think you know that we work 
closely with that advisory committee, which meets regularly and 
includes health professionals, parents of the injured children, 
attorneys, including a representative of the vaccine 
manufacturers, and nonvoting Federal personnel. The group 
advises the Secretary of the Department of Health and Human 
Services on the implementation of the program.
    Some of the provisions supported by the advisory committee 
and the Department include adding additional family counseling 
as a compensable expense--that's in Section 4(a); changing the 
procedures for the payment of attorney's fees to allow payment 
directly to the petitioner's attorney under some 
circumstances--that's in section 6; and slightly altering the 
compensation and meeting schedule of the advisory committee--
that's covered in section 8.
    The Department would support additional provisions if they 
were modified. We support with modification section 2, which 
addresses the basis for calculating projected lost earnings. We 
feel the exclusionary language, excluding the incorporated 
self-employed, should be a part of this section to prevent 
possible misinterpretation. Since the Bureau of Labor 
Statistics says that it does not and cannot tabulate the 
average earnings of incorporated self-employed individuals, we 
feel this group should be specifically excluded from the 
calculation. Without this exclusion, this section would invite 
further litigation.
    The advisory committee felt that section 11, public service 
announcement campaign, would be more useful if it were 
structured as a general publicity effort. They suggested that 
such publicity include research on the best communication 
methods and other outreach activities to increase the public's, 
the attorneys' and health care providers' awareness of the 
Vaccine Injury Compensation Fund. Thus we support section 11 
with modification.
    The Department has real concerns with section 3 of the 
bill, which would raise the death benefit from $250,000 to 
$300,000. The Department has concerns about provisions to 
increase noneconomic award payments significantly in the bill. 
In light of other provisions, that will expand the program's 
coverage and trends toward more claims being filed in the 
Vaccine Injury Compensation Program. These provisions 
collectively might lead to higher vaccine budget costs that are 
not sustainable.
    There are some provisions of H.R. 3741 that the Department 
does not support. Section 5 provides that a special master make 
an interim award for attorney's fees and costs upon completion 
of the Rule 5 conference. We support a single payment of 
interim costs, but oppose the payment of interim attorney's 
fees for several reasons. First, the Rule 5 conference is the 
first substantive status conference in a case, and, in our 
view, occurs too early for such a determination for interim 
fees or costs to be made. In addition, focusing on requests for 
interim fees diverts time and resources from the prompt 
resolution of petitions. H.R. 3741 also does not impose any 
limit on the amount of attorney's fees that may be awarded on 
an interim basis. Not imposing a cap would result in excessive 
awards and invite collateral litigation. For these reasons the 
Department does not support interim attorney's fees and only 
supports the payment of interim costs with modifications to 
section 5 as currently written.
    Although the Department supports section 7(a) of the bill, 
the general rule for the statute of limitations exclusion, we 
oppose section 7(b) which would allow a broad extension of the 
statute of limitations, enabling a filing of any claims arising 
from vaccines administered over the past 14 years. This 
provision of the bill would allow a look-back period of 14 
years for claimants who either never filed with the National 
Vaccine injury Compensation Program, or whose claims were 
dismissed by the court for not being filed in a timely manner.
    Thousands of new litigants would cause significant 
administrative burdens at the Department of Health and Human 
Services, at the Department of Justice, and on the Federal 
court, based on program experience in the 1990's when 
approximately 4,000 claims were filed over a 2-year period, 
more than a quarter of which were nonmeritorious and eventually 
dismissed by the court without medical review. A similar 
outcome might be expected should section 7(b) be enacted. The 
Department sees that outcome as harmful in that it would lead 
to long delays in pending and future claims adjudication. This 
provision, along with others, could significantly expand the 
Vaccine Injury Compensation Program, and the Department is 
concerned about the implication of this to the overall costs of 
the program. For these reasons, we cannot support H.R. 3741 as 
currently drafted.
    Our first choice would be, of course--would, of course, be 
that no child is ever injured in the attempt to protect him or 
her through vaccination. However, because some children do 
suffer injury as a result of vaccine administration, we who 
work in the National Vaccine Injury Compensation Program are 
dedicated to making compensation as fair and as expeditious as 
    I would be happy to answer any questions that you have, and 
look forward to working with you and your staff to achieve our 
common goal of a well-administered National Vaccine Injury 
Compensation Program. Thank you very much.
    Mr. Burton. Thank you.
    [The prepared statement of Mr. Hobson follows:]
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    Mr. Burton. Let me start the questions with Mr. Harris. I 
would like to ask you a few questions about the Rogers case. I 
know you can't comment about some of the specifics while it's 
being litigated, but I would like for you to try to address 
these issues in a general sense if you can.
    I know the law created an appeals process, and I know that 
you have the right to appeal these cases if you lose, but that 
doesn't mean that you have to. Is there some great principle at 
stake here that's compelling you to appeal this all the way to 
the appeals court?
    Mr. Harris. Mr. Chairman, as I indicated in my opening 
statement, we take very seriously cases that we review for 
appeal. Obviously, this would be one of them. There is a 
mandate that the Congress gave to the Department and to the 
Department of Health and Human Services in administering this 
program. That mandate is to make sure that compensation is paid 
when the medical evidence is sustainable and it's mainstream 
medical evidence, that there is a preponderance of the evidence 
that supports compensation for injuries. That is at tension 
with the idea that these claims should be processed as 
efficiently and as quickly as possible.
    We are mindful of both of those requirements in the act, 
and so whenever we decide to take an appeal, you can bet that 
it's because we feel very strongly that there are either 
medical or legal or in some cases medical and legal reasons 
that would necessitate us taking appeal.
    Mr. Burton. Well, I know you can't comment, but this is a 
case that's dragged on for 8 years. This is a family that 
doesn't have a lot of money, modest means. She is so ill, she 
can't even get out of bed. And when you make a decision on 
whether or not to appeal a case, do you take into consideration 
the situation of that family?
    Mr. Harris. In every case.
    Mr. Burton. You do. OK. Well, let me just go forward then.
    You asked the special master to reconsider her decision. 
She turned you down. You appealed to the Court of Federal 
Claims, and that was rejected. You asked the Court of Federal 
Claims to reconsider. The judge turned you down. Now, how far 
do you keep going with this thing? I mean, you know, the woman 
may be dead before you get this thing resolved. The family's 
suffered. The husband and the daughter are spending a lot, an 
inordinate amount of their time taking care of her, and they 
are incurring huge medical bills.
    The master's turned you down, the judge has turned you 
down, the judge rejected, you know, the reconsidering motion. I 
mean, to go forward after all that, it just seems like it's 
harassment, you know, harassing somebody when they are down. 
It's pretty bad.
    Mr. Harris. Well, I would first have to reject any notion 
that this is harassment.
    Mr. Burton. Well, what do you call it? You just continue to 
appeal. I mean, you have got doctors that have given evidence 
to the special master, and that evidence has been appealed to 
the judge. The judge has reviewed it. The judge has rejected 
your position. Now, you know, at what point do you say, hey, 
let's just pay these people?
    Mr. Harris. Well, we have a responsibility, as I said 
before, to make sure that in administering this program we 
protect the integrity of the program.
    Mr. Burton. Well, you know, excuse me, sir, I helped get 
this program put into place, and I can remember the discussion 
and debate about it. Henry Waxman was one of the primary 
authors of that. I don't think any of us ever envisioned this 
kind of dragging things on for 7, 8 years while somebody is 
bedridden. And even though the special master's made a 
decision, the court has rejected your position not once, but a 
couple of times, for you just to keep this up. And you talk 
about protecting the integrity of the program, that wasn't what 
we envisioned in the first place.
    Mr. Harris. Well, everything that we--all of our actions 
under this program are totally and completely consistent with 
the act that this Congress passed.
    Mr. Burton. And if we try to correct the act, we get a 
letter back from you saying, well, we don't think you ought to 
do that; and we get a letter back from the health agency saying 
they don't agree with some of these provisions that we think 
ought to be put in there to correct the situation. So, you 
know, it's a Catch-22 situation not only for the Congress, but 
for the people that are suffering. They can't get their money.
    The Congress sees the problem that you guys are--you know, 
you have gotten into the legalese of this thing. You say we 
have got to take it all the way down the road to the very nth 
degree. And, if Congress wants to correct that so we can make 
this as noncombative as possible, you guys say you don't want 
to do that because you want to protect the integrity of the 
program and the money that's in it. It sounds like you want to 
protect the interests of the pharmaceutical companies for whom 
we came up with this program in the first place.
    Mr. Harris. Well, that would be your interpretation, Mr. 
Chairman, and I respect your interpretation, but the fact is 
that in the Rogers case, I believe that there were several 
iterations of special master decisions that this is a very 
complicated situation, it is not clear-cut, and to prove that, 
I would just like to read a line from this order from the 
special master--from Judge Hodges rather, and it recognizes 
that this is a difficult case. It is a difficult case not only 
for legal reasons, which some might view as legalese, but it's 
a difficult case for medical reasons as well.
    The judge writes in the order dated February 22nd, after we 
had petitioned the court for review on this, that ``This case 
represents an unusually close question both legally and 
factually, as the special master recognizes.''
    In May 2002, after the court had accepted the special 
master's decision, which we asked for reconsideration on, the 
judge again wrote that the government--I'm quoting--the 
government has understandable concern with respect to this 
    So it is not as if we are haphazardly taking on appeals in 
these cases without any legal or medical basis for doing so.
    Mr. Burton. But the fact of the matter----
    Mr. Harris. It's been recognized by the judge.
    Mr. Burton. OK. But the fact of the matter----
    Mr. Harris. And so any characterization of our taking 
appeals that are not consistent with the mandate that Congress 
gave us to protect the legal and medical integrity of the 
program is simply false.
    Mr. Burton. Well, let my just say from a nonlawyer's point 
of view, the special master has made a decision after reviewing 
this very thoroughly and the medical records. The judge has 
reviewed it twice and has come to the conclusion that it should 
be paid. You are not a doctor, you are a lawyer, and you guys 
are doggedly going on with this thing. And it seems to me that 
a decision has been made by people who have some expertise and 
have looked at this case as thoroughly as you have, and the 
woman is suffering, and for you to go on and on and on with 
this makes absolutely no sense to me. But, of course, you guys 
are at the Justice Department, and you can do pretty much what 
you darn well please.
    Now, when we try to correct the situation with legislation 
that we think would make it easier for people to make claims 
as--and this was supposed to be a nonadversarial solution to 
the problem that the pharmaceutical companies face--it just 
doesn't happen; it's just not happening in these cases, and it 
really is troubling.
    Mr. Harris. We do not, I must say for the record, reject 
all of the suggestions that you have made in your proposed 
legislation. There are many provisions in your legislation that 
we, in fact, support, and we have made that clear to you, Mr. 
    Mr. Burton. But you don't like to look at----
    Mr. Harris. But we don't like all of the provisions.
    Mr. Burton. You don't like the look-back provision, which 
    Mr. Harris. No, we do not like the look-back provision.
    Mr. Burton. Well, and the reason, because it would be more 
    Mr. Harris. No. In fact, we don't like the 14-year look-
back provision that is proposed in 3741, and to buttress our 
case for supporting a look-back provision of 6 years, we have 
expressly stated that in our views letter that was sent to this 
committee. So it is not fair or accurate to say that we don't 
support a look-back provision because it would add new cases. 
We, in fact, do support a look-back provision of 6 years.
    We think a 14-year look-back does not inure to the benefit 
of the program, because then individuals who had filed cases 
and had those cases adjudicated would be able to refile, and 
there would more than likely be a rush of new cases filed, as 
evidenced by experience with the first statute of repose where 
we had 4,234 cases, I believe, come into the program as a 
result; that it would substantially burden the program and 
severely hamper our ability to effectively administer these 
programs. Then once, as time goes on, medical records are lost, 
witnesses lose the memory of what happened 14 years ago, is not 
as accurate or full, as complete as we would like to have so 
that we can efficiently process these claims. And the devotion 
of scarce resources and attention to these kinds of cases, many 
of which result in being dismissed because they lack 
substantial foundation----
    Mr. Burton. What about the 2-year look-back provision 
that's in there?
    What about the 2-year look-back provision that's in there?
    Mr. Harris. We support a 6-year look-back provision. That's 
greater than 2 years.
    Mr. Burton. We're talking about a 2-year timeframe for 
post-'88 cases.
    Mr. Harris. We support the provision in the bill that would 
allow anyone who experienced an onset of injury as far back as 
1996 to come into the program.
    Mr. Burton. Let me review that.
    Dr. Weldon.
    Dr. Weldon. Didn't come up with that out of thin air, you 
know. What we're interested in--the 14 years, OK?
    You know, what we are interested in doing is what is right 
for the American people. We are not, per se, interested in 
protecting your agency from being overwhelmed. We're not trying 
to look out for a ``program.'' We're trying to do what is best 
for the public, the public interest. And the reason why we 
selected 14 years is, there are cases out there that go back 
that far.
    I mean, we took testimony here in this committee from a 
doctor who has a meritorious case in my opinion, but he was 
making so much money he just paid all the bills himself, and he 
didn't even know about the program.
    I mean, this thing was so badly not publicized properly. 
And, Mr. Hobson, you said in your testimony there were 4,000 
claims and one-quarter were nonmeritorious the last time you 
had a look-back provision. So that tells me three-quarters of 
them, 3,000, were meritorious. That's our concern.
    There are thousands of people out there with meritorious 
claims. And when you draw a line of 6 years, you're telling a 
lot of people with meritorious claims, sorry, we have to 
protect the integrity of the program, we've got to do this, 
we've got to do that, we can't be overwhelmed. And so you're 
    I mean, what do we say to these constituents of ours? What 
do you recommend that we do? I mean, we are in charge, the 
Congress, of the purse strings of the Federal budget. That's 
according to my reading of the Constitution. And we vetted this 
bill with both sides of the aisle. It's the Burton-Waxman bill, 
    So you've got Democrats and Republicans supporting it. 
You've got conservatives and liberals. And I'm sorry, I don't 
feel 6 years is adequate. I mean, if you want to talk about 
some language to help you more easily deal with cases that have 
already been reviewed and dismissed, I'm very, very open to 
that, but I don't think 6 years is adequate to address the 
nature of the problem that is out there.
    Mr. Harris. Well, Mr. Chairman, you described it being the 
case that with a 6-year statute of limitations that some 
individuals with valid claims might be ``stuck,'' using your 
words. And that is a consideration that Congress, I'm sure, 
undertakes every time it imposes a statute of limitations, 
which Congress does on a regular basis; and that is, it 
involves a weighing of what is, in fact, the public interest 
with what might be the best procedure or mechanism to 
effectively establish and administer a program that meets the 
interest that Congress has designed.
    With the 6-year look back, we think that that is a--that 
reaches the balance of allowing petitioners additional time to 
file claims, which is an interest that members of this 
committee have expressed. But it does not go so far, we think, 
as to work an unfairness against petitioners who, in the past, 
filed their claims within the established statute of 
limitations, had their claims processed and awards paid under 
the compensation program, especially----
    Dr. Weldon. Reclaiming my time.
    Mr. Harris. If some of the other changes take place, such 
as the family counseling provision, the guardianship provision, 
and if there's an increase in the pain and suffering awards, as 
has been proposed in the legislation, it is very difficult for 
me to see how that is fair to the public interest for those 
petitioners who did file their claims. Given the trauma that 
these families go through, as you have identified yourself, it 
just seems a little bit unfair that that would be the case.
    Dr. Weldon. I do not--I cannot conceive how us extending 
the look-back provision for 14 years is any unfairness to those 
who filed their claims in a timely fashion when the people who 
have those claims outstanding, that go beyond 6 years, report 
to us that they were not aware of the existence of the program.
    And when you specifically testify that there are thousands 
of cases that could potentially be brought, to me, you're 
making the case for what we want to do. It suggests that there 
are thousands of cases out there when you say that.
    You know, I feel very strongly--I am specifically involved 
in that decision of 14 years. And that, as I said was not 
pulled out of thin air. There are people out there that have 
been brought to my attention that--on looking at their cases, 
that their cases have merit; and they are going to be excluded 
when you go to 6 years.
    I have another question, though, and I really want to get 
into this a little bit with you----
    Mr. Burton. Can I interrupt for a second? Let me just say 
that you make a valid point when you talk about us creating 
legislation that has a statute of limitations, and we know what 
that statute of limitations is, and we've set that. But usually 
when we set a statute of limitations, it's on some kind of an 
issue where there's no harm done to an individual.
    We're talking about people here that have been injured by 
vaccines, and they may not have been aware of the program; and 
so we created this program to be--to show a human face of 
government, as well as protect the pharmaceutical companies 
from liability suits. And we're not talking about a 7-year 
statute of limitations, for instance, where someone commits a 
criminal act and beyond that time they can't be prosecuted 
because we didn't get them soon enough.
    We're talking about someone who may be injured for life 
because of a vaccine that wasn't administered properly, or had 
some kind of an adverse impact on that person, or maybe it 
wasn't properly produced or properly tested. And it's an 
entirely different kettle of fish from the other kinds of 
statutes of limitations that you're talking about, so I don't 
think you can throw that into the mix.
    When we came up with this program, we came up with a 
program that we thought was going to be nonadversarial, that 
was going to help people get compensation for an injury. We 
didn't anticipate that people would be injured and not be aware 
of the program, and find out 10, 12 years later that they could 
have gotten compensation and now they can't because the statute 
has run out on it.
    And so the reason we put that in, as Dr. Weldon explained, 
is that a lot of these people out there deserve compensation, 
and we're saying, no, because they didn't find out about the 
program quickly enough; and we want to create--correct that 
    Go ahead, Dr. Weldon.
    Dr. Weldon. I understand, Mr. Harris, that you are trying 
to protect the program and you're trying to comport yourself 
and your office consistent with the guidelines as set forth in 
the act by the Congress of the United States. But I found the 
testimony of Janet Zuhlke regarding assertions that what she 
was doing with her daughter were cruel, to be inappropriate as 
put forth by a Justice Department attorney in the hearing that 
was held a few days ago.
    Did you hear her testimony?
    Mr. Harris. Yes, I did. And I believe I heard her correct 
her testimony, to state that the statements she was referring 
to were made by the expert witness, that a Justice Department 
attorney, in fact, did not make those statements and that the 
statement was made by an expert witness in the context of 
expressing the risks and benefits to the treatment that----
    Dr. Weldon. Expert witness called by the Department of 
    Mr. Harris. Correct.
    That a balancing of the risks and benefits of the treatment 
being weighed ought to be discussed. And there were some 
questions with regard--there were certain risks with regard to 
the treatment that, in fact, outweighed the benefits.
    And I can understand, as a parent, how having a child in 
this traumatic situation may have been interpreted as Ms. 
Zuhlke had interpreted it. But it was not made by a Justice 
Department lawyer nor would we make such a statement.
    Dr. Weldon. Well, I understand that and maybe I stand 
corrected, but it's a Justice Department witness called by your 
attorneys. And, you know, perhaps maybe you have no control 
over every word that is going to come out of their mouths. And 
I understand that from a scientific perspective, there's some 
controversy associated with the treatment that this child is 
receiving, but this is not the first time that we have been 
receiving complaints from citizens, from constituents that go 
through the program, that complain that the nature of these 
evidentiary hearings are very adversarial; and it was not the 
intent of the authors of the legislation for them to be 
conducted in that fashion.
    And I would be most appreciative if you would keep that in 
context as you continue to function in your capacity.
    Mr. Harris. I can assure you, Mr. Congressman, that I will 
do that and that our lawyers have been following that guidance 
as a matter of professionalism in the administration of the 
    I would--I have no hesitancy at all in coming to any 
conclusion that a Department of Justice lawyer would not engage 
in that kind of inflammatory or offensive exchange with someone 
who is coming to this program, especially since we truly 
understand the traumatic nature of the program in working with 
these cases on a day-to-day basis.
    And the suggestion, otherwise, I think is out of place, and 
I would welcome any showing that you may have that, in fact, 
our Department attorneys have, you know, been offensive to 
someone in this program.
    We addressed this issue the last time I testified. If there 
are cases where it is shown that a Department lawyer has, in 
fact, been offensive, we will take appropriate and corrective 
action. In the Zuhlke case, that has not been brought to our 
    Mr. Burton. May I ask a couple of questions here, Doctor?
    Dr. Weldon. I will yield to the gentleman.
    Mr. Burton. We will come back to you in just a couple 
    You talk about not being offensive. Let me just say, when a 
person has somebody in the family--a child or a wife--that's 
incapacitated and going down hill and may die, dragging a case 
out may not be analogous to asking them offensive questions 
face to face, but it certainly is offensive to those people 
because they are suffering and they consider the Government's--
what they would consider to be harsh action by dragging that 
out, when they know it's a vaccine-related injury, would be 
offensive to them.
    And I think that is what I got from Ms. Zuhlke's testimony; 
just dragging this out, asking for more and more documents 
after you had documents, and going over and over again, even 
though you may think it's necessary, to her was an offensive 
    Now let me ask you a couple of questions. The Department 
supports the doubling of the statute of limitations from 3 to 6 
years for both injuries and death cases?
    Mr. Harris. Correct. There will be a doubling to 6 years in 
both cases.
    Mr. Burton. The Department attempts to pose one claimant 
against another in the rejection of our look-back provision. 
When the program had 4,000 claims filed in 1 year, the program 
developed assistants to take on a specific number of pre-1988 
cases at a time, and notified petitioners where on the waiting 
list they were.
    If you were inundated with thousands of cases now, wouldn't 
you take a similar approach, so the existing current cases 
would continue to move forward?
    Mr. Harris. They would continue to move forward, but they 
would move forward at a much, much slower pace, which is one of 
the primary concerns of this committee. In fact, we have been 
up here before to testify about the first statute of repose and 
the lengthy delays that statute of repose resulted in with 
regard to pending cases that were post-'88 cases.
    Mr. Burton. How many lawyers do you have over there that 
work on this stuff?
    Mr. Harris. I am not sure of the exact number, but I can 
get that information for you.
    Mr. Burton. We have about $1.3 billion or $1.4 billion in 
the victim's compensation fund--1.7 billion in the Vaccine 
Compensation Fund. It seems to me that if the Justice 
Department needs more people, lawyers and analysts to process 
more cases, they ought to tell us that, because you should not 
turn down somebody's claim, or the review of someone's claim 
who has a legitimate claim, simply because the process would be 
slowed down and you don't have enough personnel to deal with 
    The victim's compensation program was set up not to 
coincide with the number of attorneys there are over at the 
Justice Department who can deal with it. It was set up to take 
care of people who were injured or the families that were 
injured. So it kind of bothers me that you say, well, if we had 
this kind of provision in there, there would be a lot more 
cases and it would slow down the process. The process shouldn't 
be slowed down. It should be brought to the Congress' attention 
that you need more personnel to deal with the increasing number 
of cases.
    As I said earlier, 1 out of 250 children, according to HHS, 
is autistic. There's a growing body of scientific evidence 
around the world that that tremendous increase is caused in 
large part because of vaccinations and reactions to 
vaccinations. Now, if you have 1 in 250 kids in this country 
that have been damaged by vaccinations, or even three-fourths 
of that, or even half of that, think of the tremendous number 
of claims you are going to have in the future. You're simply 
going to have to have more people to deal with it.
    So when you say it will slow down the process, and I deduce 
from that you don't have enough people to deal with the cases, 
then you're just going to have to get more.
    Given that you don't support the look-back provision that 
we're talking about, the 14-year, do you then support a 
clarification in existing law to provide the opportunity for 
families who have missed their opportunity in this program to 
be allowed to file their claim in a civil court and not have 
the VICP statute of limitation act against them in other 
    Let's say somebody misses the limitation period, and they 
find that they have a vaccine-related injury; they ought to 
have some recourse. They shouldn't have to sit back and say, my 
gosh, my husband, child or wife was injured by a vaccine; we're 
sure of that. Because we missed the statute of limitations, 
because we didn't know about it or some other reason, shouldn't 
we have the right to go to a civil court to try to get money 
from the pharmaceutical company that produced the product?
    Mr. Harris. Mr. Chairman, I am not aware that this issue 
has been presented to the administration. And as you know, I 
don't make these decisions myself.
    Mr. Burton. Would you support that?
    Mr. Harris. I am not in a position to say this morning 
whether the administration would support that position, but if 
you would like to present that question to us, we'd certainly 
consider it.
    Mr. Burton. What do you think personally? Don't you think 
they should have some avenue of recourse?
    Mr. Harris. Well, I'm not here to testify personally. I'm 
here to testify on behalf of the administration.
    Mr. Burton. So you don't have an opinion on that?
    Mr. Harris. I have an opinion on just about everything, but 
this is not the appropriate forum for me to express my 
    Mr. Burton. Are you refusing to answer on constitutional 
    Never mind. I'm just kidding.
    Mr. Harris. I just don't want to be fired.
    Mr. Burton. In New Jersey, a precedent has been set that 
would preclude families that opportunity if they missed the 
deadline in the VICP. A provision in the Frist bill would make 
that Federal law.
    Do you guys support the Frist bill?
    Mr. Harris. We have reviewed the Frist bill, as well as 
other legislation proposed by Mr. Greenwood and Mr. Towns, I 
believe. But I--again, I am not here this morning to express 
the administration's views on that legislation.
    Mr. Burton. But that legislation is important, and you're 
here to review the issue.
    Have you read the Frist bill?
    Mr. Harris. Yes, I have read it.
    Mr. Burton. What do you think about that?
    Mr. Harris. I am not here to testify about that. We came 
here prepared to address the chairman's bill and the provisions 
within that bill that we support and the provisions that we are 
not able to support at this time.
    And I would add, with regard to the 14-year look back that 
you propose that this is not one of the provisions that has 
been supported by the Advisory Council on Childhood Vaccines as 
well. They have not supported the 14-year look back.
    Mr. Burton. Dr. Weldon?
    Dr. Weldon. I don't have any more questions, Mr. Chairman.
    [The prepared statement of Hon. Dave Weldon follows:]
    [GRAPHIC] [TIFF OMITTED] 83515.099
    [GRAPHIC] [TIFF OMITTED] 83515.100
    Mr. Burton. Let's talk real quickly about the interim 
attorneys' fees. This is very important to level the playing 
field. You opposed our proposal because you said it's too early 
in the process. What we do is, we authorize interim legal fees 
after the rule 5 conference, which is a point by which all 
claims that don't have a reasonable basis are weeded out.
    In your letter to us, you stated that a determination that 
a claim has a reasonable basis isn't made until the end of the 
process when eligibility is determined. However, reasonable 
basis and eligibility are two completely different things.
    Can you point to a single instance in which a case was 
thrown out because it did not have a reasonable basis after a 
rule 5 conference?
    Mr. Harris. Mr. Chairman, the criteria that the courts look 
to in deciding whether a petitioner is entitled to compensation 
is the two-pronged approach, whether the petitioner has a 
reasonable basis and whether it's filed in good faith. At the 
end of the process, when it comes to awarding attorneys' fees, 
those are the same criteria that the courts look to in awarding 
attorneys' fees.
    The reason we opposed the interim attorneys' fee provisions 
of H.R. 3741 are that the award of attorneys' fees would come 
before the rule 5 conference, that this is a very early stage 
of the process, and that the litigation that would result from 
an agreement on what the attorneys' fees ought to be would 
detract attention from scarce resources in the program in 
addressing some other claims.
    This is a collateral issue that would----
    Mr. Burton. Scarce resources? There's $1.7 billion in the 
    Mr. Harris. We have 18 attorneys in the program. There have 
been 6,890 claims filed in that program; about 5,557 have been 
adjudicated. So resources are a combination of the money that's 
in the trust fund as well as the attorneys we have to process 
the claims.
    But this would be the issue of addressing the issue of 
attorneys' fees even before a Special Master has determined 
that the petition which was filed in good faith on a reasonable 
basis, would not inure to the benefit to those who have claims 
in the program.
    Mr. Burton. Isn't it true that at that point in the 
proceedings, extensive medical records and legal briefs have 
been submitted by both sides?
    Mr. Harris. Correct. Right. But a decision on whether 
entitlement would not have been made at that point in the 
    Mr. Burton. I know, but put yourself in the place of a 
mother, a single mother, who has a child that's been injured, 
and she can't afford to take care of the medical expenses of 
her child as well as the legal fees. What is she supposed to 
    She's gotten all the medical records that you have required 
up to that point. She's gotten an attorney to file the legal 
briefs up to that point. What is she supposed to do? How is she 
supposed to proceed? How can an average citizen proceed?
    Mr. Harris. Mr. Chairman, these are the rules that Congress 
    Mr. Burton. That's what I'm asking about changing this. 
This is one of the things that we talked about.
    Mr. Harris. We support the changes that would allow----
    Mr. Burton. Interim legal fees?
    Mr. Harris. Interim costs.
    Mr. Burton. Including legal fees?
    Mr. Harris. No. And we have expressly opposed the payment 
of interim legal fees.
    Mr. Burton. OK.
    Well, then I go back to my question, if you oppose that, 
how does an average mother who has this kind of a problem, 
who's paying the medical bills, how does she deal with that? 
How does she pay the legal fees?
    Lawyers don't work for nothing. The three cardinal rules 
for most lawyers is get the money up front, get the money up 
front, get the money up front.
    Mr. Harris. I can assure you that some lawyers work for 
    Mr. Burton. You have legal staffs being paid by the 
Government. And it becomes, in many cases, an adversarial 
situation. She can't afford a lawyer. What is she supposed to 
    Mr. Harris. The payment of interim costs associated with 
processing the claims, which is something that the ACCV 
supports and something that the administration supports, 
because we are cognizant of the fact that obtaining the medical 
records and other nonreimbursables, that there ought to be some 
interim payment for those types of costs.
    Now, within this program, as opposed to civil litigation--
the litigation risks are not as high within this program as one 
would find in the civil justice system, so much so that the 
attorneys that process claims in this program are virtually 
assured a payment at the end of the road. That is not true in 
your civil litigation context with respect to medical 
malpractice claims, for example.
    Dr. Weldon. Could the gentleman yield?
    Mr. Harris. To the extent that the burden would be eased by 
the Government paying the costs at an interim phase, we would 
support that. The payment of interim attorneys' fees with no 
limitation on what those fees ought to be, with the provision 
that it's not allowed for any review of the Special Master's 
decision, makes for a scheme that we can't support because it 
    Mr. Burton. What if there was a ceiling put on the fees?
    Mr. Harris. I haven't seen one.
    Mr. Burton. If there were, would that change the Justice 
Department's position?
    Mr. Harris. We would certainly consider that, but I have 
not seen it has been proposed.
    Mr. Burton. Instead of writing back saying you opposed 
that, it seems it would have been reasonable to say, if 
reasonable fees are set, and give us a figure so we can change 
that in the legislation. That's not something that we would 
look at with a jaundiced eye. We just don't want the single 
mother or these people of moderate income that can't afford it 
to not be able to pursue a valid claim.
    And let me say one more thing, and then I'll yield to my 
colleague. The main reason, as I understand it from my staff, 
that cases get thrown out, they are thrown--the main reason 
cases get thrown out on a reasonable basis ground is because 
the vaccine isn't covered by the program, No. 1; or No. 2, 
because the family missed the statute of limitations.
    Those cases are weeded out long before--the point before we 
would award interim legal fees. So when we were talking about 
interim legal fees, we were talking about, in the bill we 
proposed, when medical records have been given, when a legal 
brief has been filed, and you are there with them. I mean, we 
are not talking about something where there hasn't been a lot 
of research done.
    Mr. Harris. Mr. Chairman, two things: One, an argument that 
the parents somehow are disadvantaged by our position of not 
paying interim attorneys' costs, I would just urge the 
committee to keep in mind that the parents are not paying the 
legal fees while the case is being processed. And the attorneys 
might prefer to have some sort of payment on an interim basis, 
but it does not in any way work a hardship on the parents who 
are processing the claims through the program.
    Mr. Burton. Let me just tell you this. My grandson is 
autistic, OK? And the attorneys do take cases on a contingency 
basis, but there are very few attorneys that will take these 
cases because they take so long, and they don't know how long 
it's going to take or whether or not they'll be recognized, 
whatsoever. And they do--many of these attorneys do ask for 
funds up front in addition to a contingency agreement.
    So don't tell me these people don't have to take money out 
of their pockets, because you can't find attorneys in many of 
these cases because these cases drag on for so long.
    You anticipate that they are going to be able to go out and 
find an attorney who'll say, my child is autistic; and he looks 
at the record, and he's the guy who has worked on this thing, 
and he says, this case may take 6 or 8 years and I may never 
get anything. To find some attorney that is going to do that is 
asking him to do pro bono work for a long, long period of time, 
and most of them aren't going to do that without some money up 
front, at least the ones who specialize in this stuff.
    Mr. Harris. Mr. Homer testified several hundred cases to 
conclusion within the program; and to my knowledge, there has 
not been any showing that there is a shortage of attorneys who 
are willing to come into the program.
    And I would add that the compensation for attorneys, I 
think, has improved over the last decade. The average 
compensation for an attorney processing a claim under our 
program in 1990 was $12,500. Now it's about $37,000 and in 
2000-2001, the highest awards that were paid to attorneys for 
attorneys' fees were $301,000, $239,000 respectively.
    Mr. Burton. For 7 years of work?
    Mr. Harris. Not for 7 years of work. The average processing 
time period for a claim under this program is about 2 years.
    We are talking about cases this morning that are, as I said 
in my written testimony, the exception, not the rule. So no one 
should walk away from this hearing thinking that the average 
case in this program takes 7 years of processing--2 years.
    Mr. Burton. We had an attorney before us just a few minutes 
ago, and he said many of the cases take 7 years. You recall 
    Mr. Harris. I don't. I don't recall it.
    Mr. Burton. You weren't listening then, because he did say 
    Let me just tell you that you say there are a lot of 
attorneys out there that will take these cases, and these 
people don't have any problem. I don't know if you listened to 
any of the witnesses we have had here last year and this year, 
but we have had witnesses here that have talked about the 
problems with finding proper legal counsel to deal with their 
children's problems. And for you to say that that's not a 
problem for them is just not correct.
    They will tell you that they have had a difficult time. My 
daughter has had a difficult time. And so if you want to start 
recommending attorneys that will take these cases on a long-
term basis for no fee until the resolution of the case, give me 
a call, will you, because I don't think that's correct.
    And the Justice Department has a battery of attorneys over 
there that are on the Federal payroll, that can work long hours 
refuting these cases. And the poor moderate-income person who 
can't find an attorney to deal with that because of the 
uncertainty of the case and the length of the case, they're out 
of luck; and that's the problem.
    And we wanted this program to be a program with a heart. We 
wanted it to be a program with a heart. So if a woman like that 
woman we saw in bed was incapacitated, or a child was injured 
by a vaccine, that would be a nonconfrontational settlement of 
the case, this was supposed to be great for the pharmaceutical 
companies and great for the legal system and great for the 
person who was injured; and it ain't working out that way in 
many, many cases. And we wanted to correct that, at least in 
part with this legislation; and what we're getting back is 
opposition to a lot of it that we think is very important.
    That look-back provision for 14 years, Dr. Weldon came up 
with it because of the reasons he stated. And, you know, I just 
don't understand the Government being so recalcitrant about 
    Mr. Harris. I would just reiterate that the Government is 
not being recalcitrant about the 14-year look-back provision 
without some well-founded reasons, some of which I have been 
able to discuss this morning.
    And I would just add again that this is a conclusion that 
is concurred with by the ACCV, which is comprised of parent 
representatives, petitioners' counsel and medical experts. And 
this body of this diverse group of stakeholders in this system 
does not support a 14-year look back.
    Mr. Burton. Do you have pharmaceutical people on that board 
as well?
    Mr. Harris. It's a nine-member board, and the members are 
parent representatives, medical experts and attorneys.
    Mr. Burton. And no representatives of the pharmaceutical 
    Mr. Harris. Not to my knowledge.
    I am told there is one attorney on the ACCV from a 
pharmaceutical company.
    Mr. Burton. There is a representative of the industry on 
the board as well.
    Let me ask just a couple more questions of Mr. Hobson, and 
then we'll wrap this thing up. There's been a lot of discussion 
over the last year about whether or not an injury caused by the 
preservative thimerosal is supposed to be filed in the NVICP or 
in civil courts.
    Would you clarify if thimerosal injuries are covered in the 
program or not?
    Mr. Hobson. Just a second. Mr. Chairman, I would like to 
    Mr. Burton. You can bring one of your staff people up there 
if you like.
    Mr. Harris. I may be able to help you with that. We filed a 
statement of interest on behalf of the Government in 
consultation with Department of Health and Human Services in a 
class action suit that was filed in Oregon on the thimerosal 
issue, the issue being whether thimerosal is a part of the 
vaccine, and therefore falling within the broad scope of the 
Vaccine Injury Compensation Program; or whether thimerosal is 
an adulterant to the vaccine, and therefore outside of the 
    We filed a statement of interest in the Federal Court in 
Oregon and the case is now remanded to the State court for 
determination on that legal issue.
    Mr. Burton. So right now there is no determination?
    Mr. Harris. Our position was that the thimerosal class 
action should be within the Vaccine Injury Compensation 
Program, which is a view I think you would support.
    Mr. Burton. So--OK. In reviewing published research on 
thimerosal--and incidentally, for those who aren't familiar 
with thimerosal, it is a preservative that also includes 
mercury, and mercury is toxic to the human body, and we have 
been injecting our children with this substance for a long, 
long time even though it's been taken out of all topical 
    In reviewing published research on thimerosal, we have 
learned that in addition to concerns about the toxicity of 
mercury, that the TSA component in the preservative of 
thimerosal is highly allergic to as much as 35 percent of the 
    How is the VICP staff preparing to handle cases involving 
thimerosal? I am talking to health agencies, but if you want to 
    Mr. Harris. I thought you asked about the administration of 
claims that might be brought under thimerosal.
    Mr. Burton. OK, go ahead.
    Mr. Harris. The class action involves some--a class of, I 
believe--180 million plaintiffs in the class and as few as 30 
million in the Oregon case in the class.
    So even a small fraction of those who are in the civil 
action--if a small fraction were to pursue a claim under our 
program, obviously that would put a tremendous burden on the 
program, but it would be a burden we would have to staff up to 
meet, because we believe those claims ought to be brought into 
the program based on the mandate from Congress.
    Mr. Burton. Mr. Balbier can come up to the table with you. 
He was sworn, as well, and he has been before the committee as 
    Mr. Hobson. We are aware that some issues have been raised 
with regard to preservatives in vaccines, but I am informed we 
are in the very early stages at this point in time in 
investigating the causality associated with those 
    Mr. Burton. Well, thimerosal has been used in vaccines, I 
think, since the 1930's.
    Mr. Hobson. I was not referring specifically to thimerosal, 
but to the other ones that I think you mentioned. I think you 
mentioned TSA; is that correct?
    Mr. Burton. Right. Where are you? Have you started testing? 
Are you doing studies on that?
    Mr. Balbier. The only aspect of the thimerosal litigation 
that we're involved in is the adjudication of claims. And we 
have had a number of claims filed alleging that thimerosal has 
caused injuries, but none of those cases have gone forward yet. 
So we don't know what theories are being proposed in terms of 
the cause--of how thimerosal has caused injuries. We don't know 
what those theories are yet.
    Mr. Burton. You were here, I believe, when we had the tape 
from Canada that showed what happened to brain cells when a 
small amount of mercury is introduced into close proximity to 
those brain cells. Do you remember that?
    Mr. Balbier. I don't think I was at that hearing, sir.
    Mr. Burton. Do we have a copy of that tape? I want you to 
see that, because it shows pretty conclusively what happens to 
brain cells the minute they're--when mercury of any kind is 
introduced to them. They shrivel up and start dying 
    Seems like, to me, that if Canada has done some testing on 
this and these are medical people in Canada, that the FDA would 
have started doing some research studies on animals or 
something else. You have not yet started doing that?
    Mr. Balbier. Research is not something that comes under the 
authority we have for administration of the program. We don't 
necessarily sponsor research.
    Mr. Burton. I understand, but there's been no request from 
our health agencies to test whether or not the mercury in 
thimerosal is causing damage to brain cells?
    Mr. Balbier. I can't comment on that.
    Mr. Burton. Is there anybody here from HHS that could 
answer that? No?
    Is measles encephalitis a table injury?
    Mr. Balbier. Yes, it is.
    Mr. Burton. Is subacute sclerosing panencephalitis a 
recognized vaccine injury?
    Mr. Balbier. I'm sorry. What was the question again?
    Mr. Burton. I'm going to let my staff tell you what that 
    Ms. Clay. Subacute sclerosing panencephalitis.
    Mr. Balbier. No. That's not a table injury.
    Mr. Burton. Is it a recognized vaccine injury?
    Mr. Balbier. No.
    Mr. Burton. Individuals who join the military are required 
to get routine immunization such as DTaP, MMR, hepatitis B, 
etc. If an active duty military member suffered an injury from 
one of the covered vaccines, would they be eligible to file for 
compensation in the NVICP program?
    Mr. Balbier. Yes, they would.
    Mr. Burton. In your written testimony, you state that you 
don't support section 2 of our vaccine bill, which addresses 
the basis for calculating projected lost earnings. You state 
that the Bureau of Labor Statistics says it is not and cannot 
tabulate the average earnings of the incorporated self-
    In fact, Mr. Hobson, our staff worked extensively with the 
Bureau and learned that they do have the ability to include in 
the tabulation the average earnings of the incorporated self-
employed. This provision, in fact, would reduce litigation on 
the settling of lost earnings because it is more fair and more 
generous since it would include professionals such as doctors 
and lawyers who are often incorporated and self-employed.
    If the ability to include these earnings in the tabulation 
is possible, does this mean that the Department would support 
this provision?
    Mr. Hobson. I think that we should, at this point in time, 
revisit our consultation with the Department of Labor 
statistics on this issue, Mr. Chairman, if indeed you have 
information contrary to what I provided in my written 
testimony. We would be happy to get back to you after we make 
that contact and try to clarify the situation. It had been our 
information that basically that there would be problems with 
essentially coming up with that computation for the 
incorporated self-employed.
    Mr. Harris. And if we were to have that data, I believe, at 
least in some small measure, conflicts with the other provision 
in the legislation that would require that the computation be 
based on the gross average or mean weekly earnings of full-time 
employees, because self-employed persons are, by definition, 
not full-time.
    Mr. Burton. Subacute sclerosing panencephalitis--I'll go to 
SSPE since I can say that easier--is a progressive neurological 
disorder characterized by inflammation of the brain, 
encephalitis. The disease may develop due to a reactivation of 
the measles virus or an inappropriate immune response to the 
measles virus. SSPE usually develops 2 to 10 years after the 
original viral attack. Initial symptoms may include memory 
loss, irritability, seizures, involuntary muscle movements and/
or behavioral changes leading to neurological deterioration.
    Now the question, this is for professor--this is from 
Indiana University, Bloomington Center. Can this occur from a 
measles vaccine or the MMR vaccine?
    It cannot?
    Mr. Balbier. Our view is that it cannot.
    Mr. Burton. I wish Dr. Weldon was still here. We had a 
doctor here that had taken a sample from the spinal cord of 18 
or 20 children who were suffering from autism, and they showed 
in the spinal fluids the measles virus as well as--what was the 
other substance that was in there, do you recall?
    Anyhow, there was a very strong indication that that 
measles MMR vaccine had caused that, and he's trying to get 
that study published right now. Are you familiar with that?
    Mr. Balbier. No, I am not familiar with that study. I can't 
say that I have. It sounds like it's an unpublished study.
    Mr. Burton. It was brought up in a hearing. You may have 
been present.
    Mr. Balbier. I wasn't at the hearing.
    Mr. Burton. Here is a published study from 1997 regarding 
the measles, mumps, Rubella vaccine and this disease. A 
particular case of SSPE is described in a 13-year-old girl who 
had been immunized against all childhood diseases, receiving 
the MMR vaccine at the age of 9 months. The girl's intellectual 
functioning, until development of the illness, had been very 
good. After illness developed, the child verbalized little and 
was socially inappropriate. Her memory and thinking were 
impaired as she grew.
    The authors concluded that SSPE was engendered as a delayed 
adverse effect, as a result of the measles vaccine. The authors 
note that other cases of SSPE have been induced by the 
attenuated measles vaccine. This was published in 1997 by R.B. 
Belgamwar. Are you familiar with that?
    Mr. Balbier. No, sir.
    Mr. Burton. This is another published study here?
    I think we have pretty much covered everything we wanted to 
cover today. I have some other questions that we would like you 
to answer and submit for the record. And could you get those 
back to us, and we'll distribute those to the other members of 
the committee.
    I would like to take a look at the legal fees. If you could 
get back to us also, if there was a stated amount or some kind 
of a limit on those legal fees, if you could let us know if 
that would be something that you guys could live with in the 
legislation that we are talking about.
    Mr. Harris. In fact, in the views letter that we sent to 
your office, it is stating--and I will read directly from the 
views letter--``Imposition of a reasonable cap on interim 
awards would both protect the program and significantly reduce 
the likelihood of collateral litigation surrounding the 
determination of the appropriate interim award.'' That is in 
the letter that we sent to your office.
    Mr. Burton. Let me ask just--my staff keeps giving me these 
    Mr. Hobson or Mr. Balbier, do you agree with the decision 
to appeal the Rogers case?
    Mr. Hobson. Once again, Mr. Chairman, we are technically 
not supposed to comment because it is still in litigation.
    Mr. Burton. Given this has gone on for 8 years now and 
given that the Special Master and the Federal judge has ruled 
that this family deserves compensation, you are not going to 
give me an answer?
    Mr. Harris. With regard to the premise of the question, we 
have not made a decision on whether we are going to appeal that 
case. We filed a notice of appeal, but we have not made a 
    Mr. Burton. When will you make a decision? You can tell me 
that, can't you?
    Mr. Harris. Very soon, probably within the next week or 
two, but don't hold me to that. I am more comfortable with 
saying ``very soon.'' It's not in my control to decide whether 
we appeal this case or not.
    Mr. Burton. Since you can't talk about it, I guess I will 
have to write a letter to John Ashcroft, the Attorney General, 
and ask him to put this baby to bed, and see if he's willing to 
do that; because 8 years seems to be enough. If that means I am 
interfering with an ongoing case, then so be it. But I think 
these people have gone through enough.
    The dictionary defines compassion as, ``the deep feeling of 
sharing the suffering of another and the inclination to give 
aid or support or to show mercy.'' Just thought you'd like to 
know that.
    Thank you very much. We are adjourned.
    [Whereupon, at 1:30 p.m., the committee was adjourned.]
    [The prepared statement of Hon. Henry A. Waxman follows:]
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