Parents in court over vaccine preservative
Sunday, August 8, 2004
As parents of two severely autistic boys, Kevin and Cheryl Dass of Kansas City, Mo., face a world of heartache and worry.
Last year Kevin, a FedEx driver, and Cheryl, a part-time hairdresser, spent $27,000 on therapy for their sons. Financially exhausted, they are gnawed by these questions: How will they continue the special help that Dillon and Kyle, their 4 1/2-year-old twins, so desperately need? Will the boys -- who barely speak, are not toilet-trained and become severely upset when taken out in public -- ever be able to live on their own? If not, what will become of them when Kevin and Cheryl are gone?
"It's torn our life apart, it really has," Kevin Dass says.
And, he insists, it didn't have to happen. The boys were born prematurely and alarmingly small. Yet at 3 1/2 months, Dass says, they were given four immunizations in a single day, including three containing small amounts of mercury, a neurotoxin.
"They were still in the hospital on oxygen, staying alive, and they put this poison in them," Dass says. "They were fried. They were totally fried."
Like many anguished parents of autistic kids, the Dasses blame the condition on thimerosal, a mercury-based preservative that until recently was added to many routine children's shots.
Now, in a dispute overflowing with bitterness and rancor, more than 4,200 families are demanding compensation to help pay for their children's special needs. Their claims have inundated an obscure branch of the U.S. Court of Federal Claims in Washington, D.C., sometimes called the "vaccine court."
$2 billion trust fund
The vaccine court was created in 1986 as Congress' response to a liability crisis. In rare cases, shots were being blamed for catastrophic injuries and even death. Vaccine makers were threatening to quit the business, which in turn threatened the vaccine supply.
The National Vaccine Injury Compensation Act shielded the industry from civil litigation by instituting a system of no-fault compensation. Under the law, aggrieved families file petitions that are heard by special masters in the vaccine court. Successful claims are paid from a trust fund fed by a 75-cent surcharge per vaccine dose. The Department of Health and Human Services oversees the trust fund, with the Justice Department acting as its attorney.
The autism case is approaching a crucial stage: a hearing within the next few months in which experts will joust over whether mercury causes autism.
If the verdict is no, the case ends there. If the special master finds for the parents, individual claims will then be heard. A flood of successful claims could exhaust the $2 billion trust fund.
Thimerosal was used to keep bacteria out of vaccines sold in multidose vials. But there were no studies beforehand of its possible effects on the developing brains of infants. And health officials, who aggressively expanded immunizations during the 1990s, did not consider that mercury exposure for millions of children would exceed federal guidelines.
The parents are pushing a theory that their children were casualties of the war on disease, suffering brain damage from thimerosal by itself, or in combination with measles virus in the measles-mumps-rubella vaccine. They blame mercury from vaccines and other sources for an epidemic rise in autism and related neurological disorders.
They theorize that their children were devastated because they were less able than most children to clear mercury from their bodies.
Vaccine makers and health officials strenuously dispute the claims. While voicing compassion for the children and their families, they say there is no proof that tiny exposures -- typically 1 part mercury per 10,000 parts of vaccine -- can cause brain damage.
"There's simply no reliable scientific evidence," said Loren Cooper, assistant general counsel for GlaxoSmithKline, the global pharmaceutical giant, that thimerosal causes autism.
Dr. Stephen Cocchi, head of the national immunization program at the U.S. Centers for Disease Control and Prevention, claims that only "junk scientists and charlatans" support the thimerosal-autism link. In May, a committee of the national Institute of Medicine declared that evidence "favors rejection" of the thimerosal-autism link. Opposing studies, the panel said, were riddled with "serious methodological flaws."
In response, parent activists point out that some studies have indicated a link. They also charge that data was manipulated in one key study cited by the Institute of Medicine, and that authors of other studies had ties to vaccine makers.
More than money at stake
At stake are not only vast sums of money but reputations and careers. Vaccine makers face a potential litigation nightmare. And the allegations impugn two agencies: the Food and Drug Administration, which licenses vaccines; and the CDC, which is in charge of seeing that children are immunized against everything from polio to whooping cough.
The immunization program has been hailed as a spectacular success, responsible for saving countless children from illness and death. But if the parents are right, thousands of their children have become collateral damage.
Big vaccine makers, such as Merck, Wyeth, and Aventis-Pasteur along with Glaxo, are watching with trepidation. Although safe from liability in the vaccine court, the companies are anxious because claims have begun to appear in the civil courts.
Under the law, petitioners who have gone more than 240 days without a ruling in the vaccine court can opt out and file a civil suit. More than three dozen families who've waited long enough have opted out, and more are sure to follow. A handful of suits are set for trials next year in Texas, Pennsylvania, Maryland and Georgia.
A legal Catch-22 could doom many claims in both the vaccine court and the civil courts. The compensation law requires that petitions be filed within three years of the first sign of injury. In many cases, by the time children were diagnosed with autism and parents learned of their mercury exposure, the deadline had passed. This technicality could result in as many as 60 percent of the petitions being denied in vaccine court, attorneys for the parents say. And some civil courts have decreed that people who did not file on time in the vaccine court can't pursue civil litigation.
"The parents are going through hell. The children are going through hell," said Richard Saville, an attorney for some of the parents. "What we're trying to avoid ... is a situation in which no court ever hears their complaint."
Even so, families who reach the civil courts might gain some advantages there. They will have access to internal industry documents that are not available in the vaccine court. Moreover, while the vaccine court pays medical and living costs and as much as $250,000 for pain and suffering, civil juries can award punitive damages, too.
Vaccine makers insist their defense is rock-solid.
The evidence "is so overwhelmingly one-sided that we are confident that juries will overcome their natural sympathy for plaintiffs, and decide these cases as science dictates," said Daniel J. Thomasch, lead outside counsel for Wyeth.
But privately, some industry figures conceded that when it comes to sick children and broken-hearted parents, science doesn't always win the day.
The companies "are terrified," of huge jury awards because "the injuries are so grave," said Kevin Conway, an attorney for parents. "It's not just the kids -- it's the parents, it's the siblings. These people just live emotionally exhausted and financially devastated lives."
Even if the companies are exonerated, victory will not come cheaply. An industry representative, who predicted vaccine makers will win every case, said it could cost them hundreds of millions of dollars to do so.
Mother 'in a tunnel'
Kelly Kerns of Lenexa, Kan., who has an autistic daughter and twin sons, said: "We're not the families that are doing baseball and birthday parties.
"I'm a mother that lives in a tunnel," she said. "I haven't been to a family reunion in four years. My family doesn't understand. They wouldn't understand.
"I used to be a decent person, and I just have acid rolling from my lips every time I open my mouth," Kerns said. "I ask God every day, 'What did I do to deserve this? What did these kids do to deserve what they got?'"
Some parents are hopeful, though not holding their breath, for help from the vaccine court. Others say they'd just as soon get a chance to bloody the industry in court.
Said Georgia Mueller of Kansas City, who has an autistic son: "I want it to hurt [the manufacturers, because they] never did the research to make sure this was safe."