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Tuesday, June 05, 2007

Law - "Test Case Linking Vaccines and Autism Reaches Federal Court"

Tony Mauro of The Legal Times has a long and very informative story today headed "Test Case Linking Vaccines and Autism Reaches Federal Court." Here are a few quotes:

On June 11, the case of Michelle Cedillo * * * goes before an extraordinary tribunal assembled by the U.S. Court of Federal Claims. Its goal is to determine, for the first time in a judicial proceeding, whether the combination of certain vaccines and thimerosal, a mercury-based vaccine preservative, can cause autism -- a set of disorders that is gaining attention as more and more children are diagnosed, as many as one in 150 children born in the United States. The government has long denied such a link exists. * * *

Cedillo v. Secretary of Health and Human Services was picked as a test case from more than 4,800 autism claims that have been filed with the little-known court, which sits anonymously overlooking Lafayette Square near the White House. The outcome of the case, the court hopes, will guide the disposition of other claims and prevent the need for repetitive discovery and expert witness testimony.

The determination also could shake -- or bolster -- public confidence in the vaccine system and affect autism litigation worldwide.

During three weeks of testimony, the hotly contested issue of causation will be advanced and picked apart by expert witnesses. A sign of the emotions infused into the case: The court sealed the names of the witnesses, for fear they would be harassed.

The trial before three special masters will take place in a 400-seat courtroom that may be filled with parents and their lawyers, as well as lawyers and lobbyists for the pharmaceutical industry, which has a huge but indirect stake in the case. Special arrangements have been made to enable out-of-town parents to listen to the trial by phone, and transcripts and audio of the trial will be made available online. * * *

The question of whether thimerosal leads to autism did not surface widely until the late 1990s. Parents and autism groups now point angrily to both government and drug company documents that show questions were being raised years earlier about the safety of the mercury preservative. Environmentalist Robert F. Kennedy Jr. wrote a controversial Rolling Stone article in 2005 accusing the government of "whitewashing" evidence of thimerosal's effects.

But the government, while phasing out the use of mercury preservatives in most vaccines, still says there is "no evidence of harm" from thimerosal. A 2004 study released by the Institute of Medicine, founded as part of the National Academy of Sciences, said the accumulation of scientific evidence "favors rejection of a causal relationship."

For many, that closed the debate, but for parents, bolstered by new studies that reach the opposite conclusion, as well as their own experiences, the connection is still apparent. Future test cases before the claims court will examine whether thimerosal alone, or the MMR vaccine alone, can also cause autism.

The Cedillo trial is a crucial moment not only for the causation issue but for the vaccine compensation system, devised by Congress in 1986 to limit the liability of vaccine makers.

Broad-based vaccination is one of the success stories of the 20th century, effectively killing off diseases ranging from smallpox to polio that used to afflict millions. The compensation system was meant to handle the rare but inevitable injuries that result from allergic and other reactions to vaccines. Under the 1986 law, instead of suing manufacturers, those injured by vaccines file claims against the government in the federal claims court -- which some call the "Vaccine Court."

Special masters acting as trial judges hear individual cases and award damages once a causal connection has been made. Pain and suffering damages are capped at $250,000, but lost wages, medical and educational costs, and lawyers' fees can all be compensated. Awards can top $1 million, and more than $750 million has been paid out since the program began.

But nobody envisioned the torrent of autism claims. * * *

If causation is shown, where will the money to compensate victims come from? Under the program, patients pay a 75 cent excise tax for each vaccine, which adds $200 million to a compensation fund each year, for a current total of $2.5 billion.

So the autism litigation, even if successful, won't actually cost the pharmaceutical industry a dime. And no drug-company lawyer will have a formal role in the upcoming trial. Yet the drug companies will be watching.

One concern the companies have is the effect the case might have on public confidence in vaccines generally, says Randolph Moss, a partner at WilmerHale who advises pharmaceutical industry clients on vaccine issues. "This trial is a big deal from a public health perspective," Moss says. "There could be very dramatic public health consequences if the judges were to conclude, despite the strong scientific evidence to the contrary, that there is some connection between vaccines and autism or similar neurological disorders."

Posted by Marcia Oddi on June 5, 2007 09:53 AM
Posted to General Law Related