Vaccine Injury Claims Face Grueling Fight

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Los Angeles Times

Vaccine Injury Claims Face Grueling Fight

Victims increasingly view U.S. compensation program as adversarial and

tightfisted.

By Myron Levin

Times Staff Writer

November 29, 2004

Like good moms everywhere, Janet Zuhlke made sure her kids got their

shots.

This proved disastrous for her daughter, . She was a healthy

5-year-old until a brain injury triggered by a routine vaccination

left her

mentally retarded, physically handicapped and legally blind.

A single mother raising three daughters in Satellite Beach, Fla.,

Zuhlke

needed help with the enormous costs of 's lifetime care. So she

brought a case in a federal tribunal set up to handle vaccine injury

claims.

There, opposing lawyers hired expert witnesses to prove that 's

injuries weren't vaccine-related. When that failed, they balked at

paying

for costly medicines her doctors said she badly needed.

The Zuhlkes finally won - but it took more than 10 years.

" I thought it was very cruel, " Zuhlke said. " People were very aware

of the

fact that my family was suffering. "

The lawyers who opposed the Zuhlkes were not working for a vaccine

company

but the Justice Department. Government attorneys fought relentlessly

to

defeat a mother who thought she was doing the right thing by getting

her

daughter a government-mandated vaccine.

It wasn't supposed to happen that way in the Vaccine Injury

Compensation

Program, informally known as the vaccine court. Created by Congress

and

jointly run by the Department of Health and Human Services, the

Justice

Department and the U.S. Court of Federal Claims, it was designed to

shield

vaccine makers from damage awards that were threatening to drive them

from

the business.

It also was supposed to compensate victims in rare cases of injury

under a

flexible, no-fault system that would avoid the rancor and delay of

traditional litigation. Claims were to be handled " quickly, easily

and with

certainty and generosity, " said a House report accompanying the

legislation

in 1986.

Instead, say advocates for families with injury claims, federal

officials

often fight them with such zeal that many who deserve help are denied

it,

and even successful cases get bogged down for years.

The program " was supposed to be non-adversarial and it's become very

adversarial, " said Rep. Dan Burton (R-Ind.), whose House Subcommittee

on

Human Rights and Wellness has held hearings on the matter. Many

have " had

legitimate claims and they went on for eight, nine, 10 years. "

Vaccine compensation officials refused to be interviewed, but in

written

statements they said the program had " an excellent record of promptly

and

appropriately compensating " valid claims.

Over the years, about $1.5 billion has been paid out in compensation

and

legal fees for more than 1,800 families, most of which would have had

little

chance of winning a civil trial, the officials said. They insisted

that the

vaccine court was less adversarial than civil courts, but said they

were

obliged to fight claims that weren't based on good science.

This was " never intended to serve as compensation source for .

conditions

that are not vaccine-related, " said Joyce Somsak, the program's acting

director.

But in trying to weed out undeserving claims, critics say, the

government

has insisted on a level of proof of injury that is almost impossible

to

meet.

And a Times analysis of claims data shows that the court has become

more

unyielding over time: Officials are much less likely than in earlier

years

to concede that a vaccine was responsible for an injury or death. The

percentage of people getting awards also has declined.

Even when families do win compensation, officials have sometimes

battled

them over just a few dollars.

In one case, government representatives argued that $150 a year was

too much

to spend on wheelchair maintenance. They have haggled over how much

to allow

for replacement shoes and braces for people with polio. Another time,

they

recommended rubber sheets for the bed of an incontinent person

because they

were cheaper, although less comfortable, than disposables costing

$135 a

year.

" We never anticipated the extent [they] would go to deny these kids

compensation, " said Barbara Loe Fisher of the National Vaccine

Information

Center, who lobbied for the bill that created the program.

Viewed another way, by being tightfisted, officials have been good

stewards

of the vaccine injury trust fund, the self-insurance pool that pays

awards

to the injured. In fact, the fund - fed by a surcharge of 75 cents per

vaccine dose - has ballooned to more than $2 billion, while earning

about as

much in annual interest as it pays in awards.

But the fund was not meant to be a moneymaker. The idea was that it

was

better to " err on the side of compensating the victim, " said Rep.

Henry

Waxman (D-Los Angeles), sponsor of the legislation.

Roots of the Program

Along with clean water and sanitation, mass immunization ranks among

the

great milestones in public health. Among its glittering achievements:

Measles cases in the U.S. dropped from about half a million in 1960

to 42

last year, according to the Centers for Disease Control and

Prevention, or

CDC.

But although millions benefit, even the safest vaccines aren't safe

for

everyone.

Because of genetic differences, some people are harmed by

vaccines " that

almost everybody else responds to just fine, " said Dr. W.

Block,

former chairman of a federal advisory panel on childhood vaccines.

And some have paid a terrible price. For example, until 2000, when

the U.S.

switched from the oral live polio vaccine to inactivated polio shots,

the

vaccine itself caused a few polio cases each year.

Gordon Pierson, a 12-year-old in , Tenn., contracted polio as

an

infant this way and is paralyzed and unable to speak.

" We were doing what we thought was best for our son, and the exact

opposite

happened, " said his father, Randy Pierson. " We were just heartbroken,

and we

are every day. "

Fear of legal fallout inspired the National Vaccine Injury

Compensation Act.

At the time, vaccine makers were facing a surge in claims, mainly from

adverse reactions to the diphtheria-pertussis-tetanus, or DPT,

vaccine. An

exodus from the market and shortages seemed possible. In response,

Congress

decreed that instead of suing vaccine makers, people would first have

to

seek compensation from the new vaccine court.

Health and Human Services officials would administer the trust fund

and

screen petitions, deciding whether to concede or oppose each claim.

Justice

Department lawyers would appear in court on their behalf.

Petitioners could not seek awards for punitive damages or losses to

family

members as they could in civil court. But they were to benefit from

greater

speed and flexibility, and a lower burden of proof. Moreover, the

program

typically would pay petitioners' legal costs once the case was over,

win or

lose.

However, what was meant to be a win-win proposition instead has been

mostly

" a stupendous success in protecting the industry, " said

Washington

University law professor H. Meyers, who directs a group of law

students who represent petitioners. As for helping victims, he said,

the

record is " much more spotty. "

Some see this as a natural result of federal health officials' fierce

devotion to the immunization program - and their fear that if enough

injuries were acknowledged, people would be afraid to get their shots.

Universal immunization is a fundamental mission of Health and Human

Services. One of its branches, the Food and Drug Administration,

licenses

vaccines, and another, the CDC, promotes their use with such slogans

as

" Vaccination: An Act of Love. "

From the start, agency officials worried that the program might

create an

exaggerated public impression of the risks of vaccines. At a

congressional

hearing before passage of the bill, Assistant Secretary for Health

N.

Brandt Jr. warned that despite the program's laudable goal, it could

" provide a significant disincentive to childhood vaccination

programs. "

Burden of Proof Shifts

In 1995, the government changed the rules of the vaccine court in a

way that

made cases more contentious, protracted and harder for petitioners to

win.

Officials amended the vaccine injury table, a set of guidelines that

had

tilted many cases in petitioners' favor. According to the table, if

certain

symptoms appeared within a specified time after a shot, the vaccine

was

deemed the culprit unless the government could prove another cause.

Many

" table injuries " were simply conceded by the government, leaving only

the

amount of compensation to be determined.

A few amendments changed all that. In one major shift, " seizure

disorder "

was scratched from the table as a telltale sign of injury from a DPT

shot.

And a new, more restrictive definition of encephalopathy - or brain

dysfunction - meant that many conditions that had been table injuries

suddenly were not.

Somsak said the table was changed for one reason only: to

better " conform

with the scientific evidence. "

But the upshot was that in many cases the burden shifted from the

government

to prove the shot didn't cause injury to the petitioner to show that

it did.

Because it's usually hard to prove with certainty that a vaccine

caused

harm, the effect of the change was profound.

The Times analyzed a vaccine court database of 10,741 claims filed

over 16

years. The analysis showed that in the three years before the

changes, the

government conceded one-third of all claims. Of cases filed in that

period,

compensation was awarded in just over half.

But since the changes took effect March 10, 1995, the government has

conceded just one claim in seven. About 35% of petitioners have

received

compensation.

And cases dragging beyond five years have become increasingly common.

Even the court's top judicial officer, Chief Special Master J.

Golkiewicz, has lamented the drift toward " full-blown litigation. "

" Clearly, " he said in one of his rulings, " that is not what Congress

intended when it designed the program as an alternative to tort

litigation. "

Clifford J. Shoemaker, a lawyer for petitioners, said if the

government

softened its stance, the worst that would happen is that a " family

that

needs some money to deal with their profoundly injured child is going

to get

it. "

" Is that such a terrible thing? " he asked.

Some observers have warned that the government's uncompromising

attitude

could backfire.

Although the law directs all claims to vaccine court, it allows those

who

disagree with a ruling - or have waited more than 240 days - to sue

vaccine

makers in civil court. So far, few have.

But by their tough stance, officials may be inviting more civil

suits, Rep.

Waxman said. " The whole idea of the compensation system is to be

generous so

they [petitioners] won't want to go to court. "

Lost on a Technicality

Vaccine court officials were none too generous with Spohn.

Her parents claimed that a DPT shot caused their infant daughter to

suffer

brain damage. But they lost on a technicality: Their petition was

filed a

few hours late.

Although the vaccine compensation program was billed as more

flexible, its

three-year statute of limitations is draconian compared with rules of

civil

courts in all 50 states, which place no deadlines on the filing of

injury

claims for minors.

In the Spohn case, the doctor's records were a mess, alternately

giving July

17 and July 19, 1992, as the date of the fateful shot. The family's

lawyer

filed the petition July 18, 1995, thinking he had made the deadline

with a

day to spare. In fact, he was a day late.

Seizing on the error, the Justice Department moved for dismissal.

Special

Master concurred, citing the Spohns' " failure to use

due

diligence in pursuing the claim. "

It was " very much an injustice, " said 's mother, Spohn,

a

nurse in , Pa. " I had a normal child, and all of a sudden in

one day,

within hours of the vaccine . she became a child with a disability "

who is

" going to need assistance for the rest of her life. "

" They didn't rule that she didn't have damage. All they did was say,

you

filed 12 hours too late - too bad on you. "

Spohn said she was too heartsick at that point to look into filing a

civil

lawsuit.

" Emotionally I couldn't deal with " continuing the fight, said Spohn,

who

preferred to " accept what you're dealt with and go through life. "

Lengthy Legal Battle

In the case of Barton, the government fought so long that the

Albuquerque boy did not live to see the resolution of his claim.

As an infant, he had suffered seizures and brain damage after a DPT

shot.

But had a congenital neurological condition, known as

periventricular

leukomalacia, that the government blamed for his injuries.

His mother, Lori Barton, filed the claim in November 1991. The case

dragged

on for years. Barton told friends and family that she suspected the

government was waiting for to die - noting that it would be

cheaper

for the program to pay the death benefit of $250,000 than to buy an

annuity

to cover lifetime care.

eventually did die of a seizure, nearly six years into the

case, but

the government continued to fight. Finally in May 2000, 8 1/2 years

after

the petition was filed, the family won a ruling that 's

injuries were

vaccine-related.

Not ready to give up, Justice Department lawyers considered an

appeal. Then

they offered a deal: They would drop the challenge if the Bartons

agreed the

decision would remain unpublished. This meant it would not be sent to

legal

databases, such as Westlaw, where attorneys for other petitioners

could see

it.

Lori Barton, who has since died, described her reaction at a

congressional

hearing in December 2001: " To me, it was extortion. " But Barton, who

then

was seriously ill and had borrowed thousands of dollars to pay expert

witnesses, took the deal.

In a statement to The Times, the Justice Department said it had made

similar

deals " on very rare occasions. " It happens when the

government " disagrees

with a decision but believes that settlement is fair and in both

parties'

interests. "

Family Finances Ruined

Zuhlke's claim was filed in September 1992. The government

blamed her

brain injuries on complications from a strep infection she had about

the

same time she got her DPT shot.

Janet Zuhlke said 's illness contributed to the breakup of her

marriage. She also lost her job as a dental assistant because of

frequent

absences to deal with 's medical emergencies. Even with health

insurance, the family's finances were wrecked.

" We had a lot of hot dogs, " Zuhlke said. " We had two other children

that

went without many, many, many things . because I couldn't afford

them. "

Her case moved at a crawl, getting repeatedly reassigned to different

special masters, and from one Justice Department lawyer to another,

who

repeatedly got extensions to complete filings in the case.

Nearly eight years into the case, Golkiewicz, the chief special

master,

brought in a mediator for settlement talks. Zuhlke recalled her

despair -

and the special master's shock - when the Justice Department refused

to make

a settlement offer. " You should have seen Golkiewicz's face fall on

the

table, " she said.

Golkiewicz said recently that he was disappointed that the case didn't

settle, but that didn't mean " that one side or the other was at

fault. "

Still, he said, the case took far too long, and the Zuhlkes " had every

reason to feel frustrated. "

As it turned out, the government lost its all-or-nothing gamble. In

July

2001, Special Master Hastings ruled that was entitled to

compensation. Fifteen months later, he granted a multimillion-dollar

award,

including $925,000 for her pain and suffering, future lost earnings

and past

medical bills, and at least $90,000 a year for living and healthcare

costs.

Although relieved that the case is finally over, Zuhlke still

struggles with

grief over what happened to her child, now a young woman. 's

life, she

said, " is so different from what it should be at 20. "

And she still finds it " unfathomable " that the government fought her

claim

for so long, Zuhlke said. " My little girl hadn't done anything wrong. "

http://www.latimes.com/business/la-fi-

vaccinecourt29nov29,0,7927757.story?coll=la-home-headlines

----------------------------------------------------------------------

------

Los Angeles Times

Witnesses for Petitioners Are Often Tough to Find

Few medical experts are willing to testify in vaccine court that

shots can

cause harm.

By Myron Levin

Times Staff Writer

November 29, 2004

The vaccine court can be a hostile place not only for petitioners but

for

their expert witnesses too.

Take the case of Dr. . A neurologist and assistant

professor at

Harvard Medical School, had been retained to testify for people

with

transverse myelitis, a potentially paralyzing neurological disorder.

said he was " highly confident " that the tetanus vaccine could

trigger

the ailment in certain vulnerable individuals. Officials with the

Vaccine

Injury Compensation Program strongly disagreed.

Petitioners in vaccine court can have a tough time finding top

experts, in

part because many doctors are reluctant to say vaccines can cause

harm. But

had no such qualms.

" He was so smart, " said Sylvia Chin-Caplan, a lawyer for dozens of

victims

of the neurological ailment. " I had somebody who had academic

credentials,

who did research and had a clinical practice, " she said. " Those are

the best

people you can get. "

Then quit.

According to court papers and interviews, decided to bail out

after

complaints were lodged with his superiors by three other experts with

a long

history of testifying for the government in vaccine court.

had raised the ire of one of these men - Dr. Roland , a

prominent researcher at the National Institutes of Health. The two

had gone

head-to-head as opposing witnesses, and claimed that had

mischaracterized some of his research.

Early in 2002, was informed by his supervisors, Dr.

Hafler at

Harvard and Dr. L. Weiner of Brigham and Women's Hospital in

Boston,

where had his clinical practice, that people they respected

told them

" was ruining his reputation by his testimony in the vaccine

program, "

according to a document filed in vaccine court.

Wary of antagonizing people who could affect his career,

decided to

drop out after testifying in one last case, according to Chin-Caplan

and

other sources.

Although there were no explicit threats, Chin-Caplan said was

told in

so many words that he was jeopardizing his access to research funding.

His loss " was really heartbreaking, " Chin-Caplan said. She also

considered

it a case of witness tampering.

declined to be interviewed. None of the five other doctors - his

supervisors and the three government witnesses - would comment.

Nor would program officials discuss the propriety of their witnesses

contacting 's bosses. They said in a written statement that they

were

" not privy to and cannot control professional interactions on the

part of

VICP medical experts. "

It was not the first time a key witness for petitioners was lost to

hard-nosed tactics. Another time, Justice Department lawyers

persuaded an

expert to switch sides, helping them defeat a string of claims.

The cases involved children who suffered seizures and brain damage

after

diphtheria-pertussis-tetanus, or DPT, vaccinations. But the children

also

had a congenital condition - tuberous sclerosis, or TS - that could

trigger

seizures by itself. The issue was whether the shot or only TS was to

blame.

Petitioners won a couple of these cases in the early 1990s, thanks to

testimony by Dr. Gomez of the Mayo Clinic, described in court

rulings

as " the world's expert in TS. "

Facing at least two dozen similar claims, the government mounted an

aggressive counterattack. It retained three experts who then

published three

medical journal articles that supported the government's stand,

according to

program records.

And without the knowledge of petitioners, government attorneys also

contacted Gomez, briefed him on the work of their other experts and

retained

him as a defense expert.

Gomez was " the guru of tuberous sclerosis, " said Moxley, a

Wyoming

lawyer for petitioners. His defection " was completely pivotal. " Like

Chin-Caplan, Moxley described the government's actions as witness

tampering.

In September 1997, Special Master Millman issued a lengthy

ruling in

the government's favor - basically finding that TS, not the vaccine,

is

usually responsible when TS infants suffer seizures. Gomez, Millman

noted,

had believed otherwise, " but in light of his more thorough education

in the

literature (courtesy of respondent) he has changed his mind. "

Her ruling led to the defeat of most TS claims.

Contacted recently, Gomez said he had altered his opinion " mainly from

accumulated evidence. " Otherwise, he said, " I don't think I have much

to

tell you. "

Millman's ruling was affirmed in 2001 by the U.S. Court of Appeals

for the

federal circuit, which also found no proof of improper conduct in the

government's hiring of Gomez.

http://www.latimes.com/business/la-fi-

vaccineside29nov29,1,5207418.story?coll=la-home-headlines

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