Vaccine Injury Compensation: A Failed Experiment in Tort Reform?

[Guest guest]

Vaccine Injury Compensation: A Failed Experiment in Tort Reform?

by Barbara Loe Fisher, from the NVIC newsletter.

On Nov. 14, 1986, President Reagan signed the National

Childhood Vaccine Injury Act of 1986 into law, instituting first-time

vaccine safety reforms in the U.S. vaccination system and creating the

first no-fault federal vaccine injury compensation program alternative

to a lawsuit against vaccine manufacturers and pediatricians.

Twenty-two years later, on Nov. 18, 2008,I made a statement (Statement

— Barbara Loe Fisher, Nov 18, 2008 — Advisory Commission on Childhood

VAccines) to the Advisory Commission on Childhood Vaccines (ACCV) and

questioned whether the compensation program is fatally flawed and so

broken that it should be repealed. Many parents are wondering whether

it would be better to return to civil court without restrictions to

sue vaccine manufacturers and doctors for injuries and deaths their

children suffered after receiving federally recommended vaccines.

During its two-decade history, two out of three individuals applying

for federal vaccine injury compensation have been turned away

empty-handed even though to date $1.8B has been awarded to more than

2,200 plaintiff's out of some 12,000 who have applied. Today, nearly

5,000 vaccine injury claims are sitting in limbo because they

represent children, who suffered brain and immune system dysfunction

after vaccination but have been diagnosed with regressive autism,

which is not recognized by the program as a compensable event. There

is $2.7B sitting in the Trust Fund which could have been awarded to

vaccine victims.

At the time of the law's creation in 1986, Congress said they were

committed to setting up a fair, expedited, non-adversarial, less

traumatic, less expensive no-fault compensation mechanism alternative

to civil litigation. But Congress also acknowledged that any

legislation providing liability protection must also be equally

committed to preventing vaccine harm. The Act contains strong safety

provisions, including first-time mandates for doctors to record and

report serious health problems, hospitalizations, injuries and deaths

after vaccination and give parents written benefit and risk

information before a child is vaccinated.

But few of the safety provisions have been enforced and, as I

testified in Congress in 1999 and again at the Nov. 18 ACCV meeting,

there has been a betrayal of the promise that was made to parents

about how the compensation program would be implemented. Obtaining

compensation has become a highly adversarial, time-consuming,

traumatic and expensive process for families of vaccine injured

children and far too many vaccine victims have been denied

compensation while vaccine makers and doctors have enjoyed liability

protection and dozens of doses of nine new vaccines have been added to

the childhood vaccine schedule.

I pointed out that federal court judges are beginning to look back at

the legislative history of the Act, which so clearly affirms the

intent of Congress when creating it. In recent court decisions, judges

have agreed with parents and their attorneys that the compensation

program has become far too difficult for plaintiffs. A recent state

Supreme Court ruling also reiterated that Congress never intended to

shield vaccine manufacturers from ALL liability for vaccine injuries

and deaths when it could be demonstrated that a safer product could

have been marketed.

In a Supreme Court of Georgia ruling on October 6, 2008 in American

Home Products v. Ferrari, the justices unanimously held that the

National Childhood Vaccine Injury Act does not give a vaccine

manufacturer blanket immunity from vaccine injury lawsuits if it can

be proven that the company could have made a safer vaccine. Georgia

Supreme Court Justice Carley wrote that the 1986 law and " the

congressional intent behind it shows that the Vaccine Act does not

pre-empt all design defect claims. " He added that Congress did not

" use language which indicates that use of the compensation system is

mandatory " but only " an appealing alternative " to the courts.

Justice Carley wrote that there is no evidence that " FDA approval

alone renders a vaccine unavoidably safe " and said " We hesitate to

hold that a manufacturer is excused from making changes it knows will

improve its product merely because an older, more dangerous version

received FDA approval, " adding that to do so would have " the perverse

effect " of granting complete immunity from liability to an entire

industry and he concluded that " in the absence of any clear and

manifest congressional purpose to achieve that result, we must reject

such a far-reaching interpretation. "

During the ACCV meeting, longtime plaintiff's attorney Sherry Drew

gave a moving description of the suffering that families with vaccine

injured children endure and, during public comment at the end of the

meeting, Jim Moody, of SafeMinds, and Vicky Debold, RN, PhD joined me

in urging the Committee to recommend to the new Secretary of DHHS that

more vaccine injured children be compensated. This was echoed by

outgoing parent ACCV member Tawny Buck, of Alaska, who has a DPT

vaccine injured daughter and new ACCV parent member Hoiberg, of

Florida, who has a DTaP vaccine injured daughter.

In the 1986 Vaccine Injury Act, the Institute of Medicine was directed

to review the medical literature for scientific evidence that vaccines

can cause injury and death, which resulted in landmark reports to

Congress in 1991 and 1994 providing that evidence. IOM announced at

the ACCV meeting that it has recently been contracted by the Health

Resources & Services Administration (HRSA) to assemble a Committee of

scientific experts to review of the medical literature for evidence

regarding the biological mechanisms for injury and death in

association with varicella zoster (chicken pox), hepatitis B,

meningococcal and HPV vaccine. There will be several public workshops

during the Committee's two- year study.

NVIC has been calling for basic science research into the biological

mechanisms of vaccine injury and death for more than two decades.

Without understanding how and why vaccines can cause brain and immune

system dysfunction, there will be no way to develop pathological

profiles to help scientifically confirm whether or not an individual

has been injured or died from vaccination.

The truth about vaccine risks lies in the science, properly designed

and conducted. The upcoming IOM review may be hampered by a lack of

biological mechanism studies published in the medical literature but

the review is also an opportunity to point the way to fill in those

gaps in knowledge and the need for additional research that could

become part of a national vaccine safety research agenda.

In the absence of scientific certainty, all children who regress into

poor health after vaccination should be given a fair hearing in the

federal vaccine injury compensation program and generously compensated

when no other plausible cause can be found for what happened to them

after vaccination. Congress intended the vaccine injury compensation

program to be non-adversarial, fair, generous and humane. If it cannot

function the way it was intended to function, then parents have every

right to call for its repeal and a return to unrestricted lawsuits.