Inside the “Vaccine Court”

Posted on Jul 29, 2008 in Autism, Heavy Metals

A court with no judge, no jury and a controversial treatment of science takes center stage in the autism-vaccine debate.

Kevin Conway, a vaccine injury lawyer who represents hundreds of families with autistic children, does not beat around the bush when he discusses the facts in his cases. “I agree that there is no scientific proof that vaccines cause autism,” he says.

It may seem counterintuitive that the absence of scientific evidence isn’t enough to merit the dismissal of every one of the 5,000 autism cases pending in federal court, including all 1,200 of Conway’s. However, these cases are being heard in a “vaccine court” that employs a considerably different decision-making process than scientists and even most courts do. In the wake of the recent ruling that vaccines contributed to 9-year-old Hannah Poling’s autism, the vaccine court is suddenly in the spotlight, and its approach toward weighing evidence is being criticized.

Many doctors and government officials worry that parents will mistakenly interpret the court’s findings as scientific conclusions and make rash decisions to stop immunizing their children, potentially causing outbreaks of vaccine-preventable diseases. They fear that the very program Congress created to protect universal vaccination could inadvertently play a part in undermining it.

“The message can definitely get misconstrued,” says Dr. Jennifer Shu, an Atlanta pediatrician and spokesperson for the American Academy of Pediatrics. “People are implying that vaccines are the cause even though that’s not what the court said.”

In 1988, reacting to a different anti-vaccine protest that focused on the neurological side effects of the diphtheria-pertussis-tetanus (DPT) vaccine, Congress established the National Vaccine Injury Compensation Program. The idea was to maintain successful national immunization while also providing fair damages to people harmed by vaccinations. Through the program, funded by a 75-cent tax on vaccines, the government shields drug companies from lawsuits that might dissuade them from producing vaccines vital to public health. The federal government acts as the defense in cases before the U.S. Court of Federal Claims, a.k.a. the vaccine court, which then awards appropriate compensation. The claiming party can only take its case to other federal courts after a decision from the vaccine court, which typically takes two or three years.

Over the next few years, the court will set criteria for deciding the thousands of pending autism cases based on testimony in test cases that explore the link between autism and the measles-mumps-rubella (MMR) vaccine, the mercury additive thimerosal and a combination of the two. The court heard the second round of these test cases in May.

In February, documents leaked to Huffington Post blogger David Kirby revealed that last year the government had awarded compensation to the Poling family, who claimed that vaccines had aggravated Hannah’s preexisting mitochondrial disorder and led to autism. Officials from the departments of Justice and Health & Human Services, who represent the government in vaccine court, conceded the case in November without a trial.

Mainstream media quickly picked up the story, while some activists claimed that the government had admitted vaccines cause autism. However, government health officials emphasized that Hannah’s rare disorder made the case irrelevant to almost all of the pending autism claims—although nobody knows how many other cases involve patients with malfunctioning mitochondria, the powerhouses of the body’s cells.

The buzzword over the vaccine-autism controversy is causation, specifically the difference between the scientific and legal definitions. If a case ends up in a regular civil court against a vaccine maker, lawyers have to prove both that the vaccine led to the injury and that the manufacturer knowingly distributed a harmful product. According to Stephen D. Sugarman, a law professor at the University of California, Berkeley, many federal judges would throw these autism cases out without letting them reach a jury because of failure to satisfy the latter requirement. However, since the vaccine court’s decisions place no blame on vaccine manufacturers, the outcome of each case relies solely on whether the vaccine causes injury—making the role of science in proving causation such a pivotal issue.

For scientists, evidence of causation can only result from carefully controlled, peer-reviewed clinical studies. The data would have to establish 95 percent confidence that such a link existed—in other words, science’s version of beyond a reasonable doubt. When it comes to vaccines and autism, an overwhelming majority of studies have found no such evidence. A 2004 report from the Institute of Medicine cited 19 large studies that found no link between autism and either the MMR vaccine or thimerosal.

These data should dictate the course of vaccine injury lawsuits, says Dr. Paul Offit, the chief of infectious diseases at the Children’s Hospital of Philadelphia and an outspoken critic of autism-vaccine activists. “If you were reasonably trying to determine if vaccines could cause autism, the best way would be to sit down 20 people who are experts and have them review all the scientific literature,” he says.

But in the vaccine court, the burden of proof is drastically lower than science’s. Like a civil court, its decisions rely on a preponderance of the evidence. If the court decides that the position of the person making a claim (the petitioner) is more likely than not to be correct, then the petitioner wins. Conway, the vaccine court lawyer, calls it “50 percent and a feather.” The court has also adopted a tie-goes-to-the-runner mentality, thanks to a 2005 federal appeals court decision, in which borderline cases tend to go to the petitioner. As a result, the vaccine court has awarded compensation in almost a third of the roughly 7,000 cases it has heard since 1988, adding up to $1.8 billion in damages.

The vaccine court has other distinctive qualities, too. Instead of a judge or jury, appointed lawyers known as special masters preside. Rather than employing the rigid structure of the scientific method, the court’s guidelines emphasize informality, stating that “special masters are not bound by formal rules of evidence” and that both sides should “be creative” in presenting their arguments “quickly and less expensively.”

To prove legal causation, the petitioner must present a medical theory that includes a “logical sequence of cause and effect showing the vaccine was the reason for the injury.” In essence, petitioners must prove that the vaccine best explains the injury, not that it definitively triggered it. Rather than relying on published data and scientific consensus, explanations of causation can also come from the testimony of medical expert witnesses called by the petitioners.

Offit, who is also the co-inventor of a rotavirus vaccine, calls these standards irrational, particularly the marginalizing of published scientific data in favor of expert testimony. “I’m sure you can find one to say the Earth is flat,” he says caustically. With this in mind, government lawyers have filed legal briefs urging the special masters to act as gatekeepers against unreliable science.

Dr. Marcel Kinsbourne, a pediatric neurologist and professor at The New School in New York who has testified on the behalf of families in the autism test cases, disagrees. “I turned down many cases because I didn’t feel there was enough evidence,” he says. “If a case is poor, the attorneys will not find experts.” He says the special masters can judge the credibility of evidence based on the witnesses’ level of expertise and experience.

One recent case serves as a model of the dichotomy between science and the vaccine court. In 2006, the court awarded 47-year-old Dorothy Werderitsh compensation for her multiple sclerosis that developed after receiving hepatitis B immunizations. Despite a detailed report by the Institute of Medicine concluding no evidence of causation, the court granted Werderitsh compensation based primarily on expert witness testimony.

This case clearly demonstrates the special masters’ willingness to abandon peer-reviewed science in making legal judgments, a principle critical to the autism petitioners’ chances. But to scientists like Offit, the case illustrates the major flaw in the court’s decision-making process—and a source of worry in awaiting the autism decisions.

While the Werderitsh verdict did not prompt a flurry of further hepatitis B-multiple sclerosis claims or a public outcry to skip the vaccine, the autism proceedings have garnered far more public attention. With the media trumpeting every new development, what will happen if the court’s decision breaks from scientific consensus, as it did with the Werderitsh case?

All 50 states require children to receive vaccinations prior to entering school, but 48 offer religious exemptions and 21 allow personal belief exemptions. A breakdown in the public’s confidence in vaccines, perhaps ignited by a vaccine court ruling, could lead to a sharp increase in deadly infectious diseases like measles. Curtis Allen, a spokesman for the Centers for Disease Control and Prevention, would not address the autism hearings but said “there are concerns over falling immunization rates.”

As of June 13, there were 78 confirmed cases of measles in the United States in 2008, compared to 43 all of last year. In the United Kingdom, where immunizations are not mandatory, the MMR vaccination rate has fallen to 86 percent. Measles incidence in England and Wales ballooned from 78 cases in 2005 to 971 last year.

Shu, the Atlanta pediatrician, hopes the special masters understand the public health consequences when they rule on the autism test cases. Many pediatricians noted a sharp increase in scared parents immediately following the Hannah Poling announcement, according to Shu. “I’m not confident, but I am optimistic that based on the public response, there will be a little more care going into these decisions,” she says.

But Robert Krakow, a lawyer who founded an advocacy group for children allegedly injured by mercury-containing vaccines and who represents about 100 autistic children in vaccine court, downplays the potential for a public health crisis. He says parents are already losing faith in vaccine safety because the government is providing “empty reassurances without accurate testing.”

Krakow, who filed his own claim on behalf of his autistic son, believes the petitioners have provided sufficient evidence to prove their case. “If we get a fair-minded decision we absolutely should win . . . but I’m a little bit dubious whether we’re going to get a fair result,” he says. While he believes the special masters will try to judge fairly, he foresees tremendous pressure from public health officials to deny these claims.

Nobody knows how the court will rule or what the public response would be if the special masters award compensation. But there is no doubt that tensions are building in the courtroom at the U.S. Court of Federal Claims in Washington, D.C. People on both sides of the debate are taking the autism trials extremely seriously.

“The proceedings have become much more militant,” says expert witness Kinsbourne. “Both sides see so much depending on the outcome.”