VACCINE INJURY COMPENSATION PROGRAM UNDER FIRE

[Guest guest]

Aug 12,1998

Vaccine payback program criticized

Published in the Home News Tribune 8/12/98

source: http://www.injersey.com/news/hnt/story/0,2109,102778,00.html

By JOHN HANCHETTE and SUNNY KAPLAN

GANNETT NEWS SERVICE

WASHINGTON -- A quiet, decade-old federal program designed to compensate

children injured by vaccines is sliding into controversy as critics

label it unfair, ineffective and a corruption of congressional intent.

The National Vaccine Injury Compensation Program was established in 1986

to replace contentious, costly and unpredictable product liability and

medical-malpractice lawsuits that so worried the big pharmaceutical

companies that they threatened to stop manufacturing vaccines.

The new compensation program was to establish a nonadversarial

" no-fault " system -- one giving aggrieved parents a medical benefit of

the doubt in claims that their infants and toddlers were injured or

killed by reactions to childhood shots against several diseases. It

would provide, promised , an official of the American

Academy of Pediatrics, " simple justice to children. "

Instead, a four-month, computer-assisted investigation by Gannett News

Service, supplemented by government responses to six separate Freedom of

Information Act requests, shows: The relatively obscure program, which

officials poor-mouthed as

underfunded until five years ago, now has a built-up compensation pot of

$1.3 billion. It has an annual income of $240 million, with most of it

coming from a 75 cents-per-dose excise tax on the childhood shots.

" There is far too much money coming in, " acknowledged program director

Balbier.

Despite the impressive nest egg, a compensation program database

supplied GNS shows that in cases going to adjudication, the program has

turned away without awards 75 percent of 5,300 claimants since

inception. Those figures don't include settlement before hearing. A new

study by the Federal Judicial Center shows settlements increase the

percentage of awards, but only to slightly less than 30 percent.

Envisioned by Congress as a simple process administered by the US Court

of Federal Claims, the program enlists 17 full-time Justice Department

lawyers, all litigation experts, to fight almost every death claim. Only

one-third of the 771 death cases so far have been compensated, the

database shows.

Although the volume of cases peaked in the early 1990s, almost 800

remain to be adjudicated, and the pace has slowed significantly in

recent years. Balbier said this is because " only the most complicated

ones are remaining " after the Court of Claims cleared a large backlog

earlier in the decade. Congress stated that vaccine death-and-injury

awards should be made " quickly, easily, and with certainty and

generosity, " but several families awarded compensation still await

payment, some three to five years after the original ruling. Balbier's

office insisted uncompensated families number 15. The program database

shows 60 cases in this category.

Larry Gray, a home repair salesman from Harrah, Okla., falls into the

category of those long awaiting payment. He first filed a claim for his

blind, nonspeaking, chair-confined son , now 9, in 1989. In

August 1993, he won a ruling that the DTP vaccine was to blame and that

his son was entitled to compensation. So far, Gray has seen zero.

The Justice Department kept questioning the life-care plan. Finally, on

Friday, Gray and his Idaho attorney Curtis Webb stipulated to

compensation of what will amount to about $2 million if the boy lives to

be 20. His doctors have told him he won't. Gray should have funds for

long-term care by November. In serious-injury cases like 's,

life-care plans must be worked out even after compensation is awarded.

And Justice lawyers sometimes spend months squabbling over expenses like

the projected cost of diapers in a certain state in the next century.

Since such children have a shortened life expectancy and since unused

compensation dollars go back to the government if an injured child dies,

parents of such children are understandably suspicious of delays.

Some lawyers experienced at bringing claims are so frustrated with the

federal program they are threatening to abandon it and return to the

practice of suing doctors and the big drug companies that make the

vaccines. But Balbier insisted the program does not unnecessarily delay

claims. " We have every interest in trying to have these cases

adjudicated as quickly as possible, " he said. " The program has been

extraordinarily successful on that level. It takes an average one to two

years to get through the system from the time a claim is filed. " If

families go through the courts, he said, it could take seven to eight

years. To win compensation, it used to be enough to demonstrate certain

timely symptoms. But three years ago, Health and Human Services

Secretary Donna

Shalala, according to critics, gutted The program's Vaccine Injury Table

associated with the most reactive of childhood vaccines: the DTP shot.

DTP stands for diphtheria, tetanus and pertussis (or whooping cough).

And of $916 million awarded in compensation since the start of the

program, $739 million, or 81 percent, has been for DTP cases. Scientists

say the culprit in DTP reactions is the pertussis portion of the

inoculation, mainly because it is made from the killed whole cells of

pertussis bacteria. Shalala raised the bar on standards of DTP vaccine

injury by deleting seizure and shock-collapse disorders, making

anaphylactic reactions occur within four hours of the shot, and

drastically redefining evidence of acquired brain

damage or brain inflammation to a stupor that persists for at least 24

hours and requires hospitalization.

" The DTP kids are going to start losing by the trainload, " predicted

California lawyer Dodd. " The new standards are very difficult to

meet. You have to have, basically, a child in a coma within 72 hours. "

Vaccine-injury lawyers appealed Shalala's changes immediately to the

U.S. Court of Appeals, claiming she did not have authority to change the

injury table. The court ruled in Shalala's favor, giving the HHS

secretary broad

power to make medical decisions in the future. Barbara Fisher, founder

of the Virginia-based National Vaccine Information Center, a group of

parents and health advocates concerned about vaccine safety, thinks

Shalala changed the rules because the huge agency felt too many awards

were being made for DTP injuries and deaths, and " each award is an

acknowledgment the vaccine can kill and injure. "

Shalala refused repeated GNS requests to answer specific questions about

the program and vaccines, instead issuing a boilerplate endorsement of

childhood vaccinations.

" Like other medications, vaccines will never be 100 percent safe -- but

they save thousands of our children's lives every year, " she said in her

statement. " For those very few cases where a vaccine may cause an

injury, we need to provide fair compensation. We also need to work

vigorously to provide the safest possible vaccines. But most of all, we

must not forget the great benefit we are gaining from widespread

vaccination. " Criticism of the 10-year-old compensation program may

evolve into a lively public policy debate. A concerned Rep. Henry

Waxman, D-Calif., who as chairman of the House Health Subcommittee

helped mold the compensation system, said he will recommend to the

subcommittee's current chairman, Rep. Bilirakis, R-Fla., that he

have hearings on the program and the vaccine injury table.

Bilirakis said he would consider hearings. Vaccines are the only

substance Americans are forced to put in their bodies. State and federal

governments, to control disease, demand it of citizens or they will be

shunned from normal society: denied admission to day-care centers,

schools, colleges, the military, health-insurance coverage, some jobs.