June 5, 2007

Legal Times: Vaccine Omnibus Hearings

UPDATE: Welcome Wall Street Journal Readers. For helpful background on the Thimerosal, Vaccine research, and daily hearing updates, visit this post. Enjoy!

Test Case Linking Vaccines and Autism Reaches Federal Court
Tuesday June 5, 3:02 am ET
Tony Mauro, Legal Times

The family stories are remarkably, painfully, similar.

They begin begin with toddlers developing well, and happily. Then they are taken to the doctor's office for routine vaccines which, in the early 1990s, often were bundled together.

A week after the shots, the devastation begins: loss of speech and eye contact, high fever, constant pain, screaming, bowel problems, no sleep. The children no longer respond to their names; later, they are diagnosed with autism or related disorders.

"Words alone cannot explain the trauma of watching your only child's health deteriorate to such a degree before your eyes," Theresa Cedillo of Arizona writes in an e-mail to Legal Times.

On June 11, the case of Michelle Cedillo, Theresa's daughter, 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.

In her first comments to the media since her case began in 1998, Theresa Cedillo tells Legal Times, "The profound downward change in Michelle's health began seven days following the MMR [measles, mumps, and rubella vaccine]."

Of her daughter, now 12, she adds, "Her childhood has passed right before our eyes spent in hospitals and doctors' offices, not in parks and with little friends. The trauma of the sheer human suffering she endures every day is beyond explanation and understanding, filling us with overwhelming anguish."

Michelle, her mother says, "will require a very highly skilled and involved level of daily care as she continues to age ... It is our hope that she can gain some type of communication skills in the future."

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.

"There's never been another case like this," says Kevin Conway of Boston's Conway, Homer & Chin-Caplan, one of Cedillo's lawyers.


The proceeding is more than five years in the making. The plaintiffs lawyers and the government, with an occasional assist from pharmaceutical companies, have been jockeying over discovery issues for years. On May 25, the special masters denied a long-pending request by the plaintiffs for access to a massive vaccine database developed by the government's Centers for Disease Control and Prevention and private managed-care organizations.

"It's infuriating," says Conway, asserting that the database would have been an important resource for Cedillo's witnesses. Instead, he says, about 250,000 other documents have been released over the years, which Conway describes as "a haystack without a needle -- useless."

Some lawyers also question whether Cedillo's was the right one to pick as a test case. Michelle's extreme reaction, while not rare among claimants, may not result in a ruling that that will help children with a less severe or more delayed injury. "Her case may be too strong," says Curtis Webb, a plaintiffs lawyer from Twin Falls, Idaho. "I wonder if a ruling in her favor will let other kids win."

Rita Shreffler of Nixa, Mo., is one of the parents who hopes to be in the audience for at least some of the trial. Shreffler is the mother of Andrew, 15, and Mary, 13, both of whom have autism -- both, she believes, the result of childhood vaccines.

"They were totally normal until about 18 months," she says in a phone interview. After their routine vaccinations, "I saw them slip away. There were really drastic personality changes." Andrew cried constantly, she recalls. "I swear he didn't sleep for three years."

Shreffler, now executive director of the National Autism Association, has joined the upcoming claims court litigation on behalf of her children. "If you look at the scientific evidence, it's a no-brainer" that the mercury in the thimerosal preservative caused or contributed to their autism. "My son got a level of mercury injected into him, which, under [Environmental Protection Agency] guidelines, would be safe only if he weighed 1,100 pounds."

That mercury was delivered in the form of thimerosal, a preservative that is nearly 50 percent mercury.

With the addition of more vaccines -- for Haemophilus influenzae type B (Hib) and hepatitis among others -- to the typical regimen in the 1990s, children were exposed to more and more mercury.

"We were set up for disaster," says Cheryl Gaudino of Attleboro, Mass., another parent who believes there is a vaccine-autism connection. In 1997, when he was 13 months old, Gaudino's son Ryan was given the Hib and MMR vaccines during a doctor's visit for an ear infection. He'd had several rounds of antibiotics for earlier illnesses, so his immune system was already compromised, she says.

Within days, Ryan had an intense allergic reaction and developed vasculitis. "That means the valves in your veins leak," Gaudino says. "There is pooled blood under the skin. He looked like a burn victim." A photo from that time confirms her description.

Ryan recovered, but then lost language skills and continues with severe problems. "He can get out some of his wants," says Gaudino. "He will screech; he can hit himself; he can hit you."


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.

"This is the biggest group of cases we've ever handled," says Gary Golkiewicz, the court's chief special master. Cedillo and future test cases, says Golkiewicz, "will be critical in presenting the issues so we can get these decisions out as quickly as possible."

More than 5,100 autism-related claims have been filed since 1999 (some have been withdrawn) compared to 2,700 for all other vaccine claims since the program started operating in 1988.

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."

The CDC has voiced similar concerns, and pro-vaccine groups are approaching the media in advance of the June 11 trial.

But Jared Hansen of Framingham, Mass., sees an inherent conflict of interest for the CDC. "The same agency that is responsible for promoting vaccines is also assessing their risk," Hansen says. "It's a real tangle."

Hansen is another claimant in the upcoming autism litigation. His sons Jacob and William both have autism. Their problems began soon after they received standard vaccinations as toddlers. Jacob was not diagnosed with autism until after William was born and had received vaccinations.

Hansen says his main hope for the trial, which he will follow on the Internet, is that "the science finally gets a hearing." He has an open mind about it and says more research is needed.

"There is science to be done, yes," he says. "But with children involved, shouldn't we err on the side of safety?"

No comments: