Lilly in lawyers' cross hairs again

Lawsuits suggest vaccine may be linked to autism

By Jeff Swiatek

jeff.swiatek@indystar.com

July 14, 2002

No one knows for sure why autism is spreading among young children, but that hasn't stopped some trial lawyers from targeting a prime suspect in their eyes:

Eli Lilly and Co.

The Indianapolis drugmaker faces at least 45 lawsuits over its role in developing and selling for more than 40 years a mercury-based preservative used in childhood vaccines and now suspected of causing autism.

Though the first case won't come to trial before next year, the lawsuits pose a potential costly threat to Lilly and a handful of vaccine makers also named as defendants.

In an era when product-liability suits against big companies can result in jury awards in the millions or even billions of dollars, few cases can compare in jury-awakening pathos to toddlers stricken with autism. A puzzling neurological condition, autism can trigger profound mental problems in a healthy child within months and wreak havoc with families.

Since the alarm was sounded in 1999 that mercury-based preservatives in vaccines might be linked to autism, trial lawyers have met regularly to plan their legal assaults on behalf of autistic children and their parents.

"I think the damages are catastrophic. One case certainly could be worth millions," said Michael J. Miller, senior partner for Miller & Associates, an Alexandria, Va., law firm that's filed three lawsuits against vaccine makers and Lilly.

Nationally, more than 60 lawsuits have been filed against vaccine makers, including such big firms as Aventis, GlaxoSmithKline, Merck, and Johnson & Johnson. The litigation has the potential to sign on thousands of plaintiffs, said attorney C. Andrew Waters, whose Dallas firm Waters & Kraus has taken a leading role in autism cases with more than 50 filed.

Waters thinks juries will sympathize with plaintiffs who can show that drugmakers knowingly sold vaccines containing mercury in doses much higher than allowed under federal guidelines. "It just boggles the mind (how) you inject someone, much less an 8-pound baby, with one of the most toxic substances known to man."

Mercury is a notoriously toxic metal that accumulates in the body and can cause severe brain damage.

Bad timing

Getting caught up in the autism litigation could hardly come at a worse time for Lilly.

It already faces the loss of more than $2 billion a year in revenue from Prozac, its former best-selling drug that lost patent protection last year. And it's spending millions of dollars and redeployed hundreds of workers to respond to tougher Food and Drug Administration scrutiny that has delayed approvals of at least three key upcoming drugs and forced an overhaul of manufacturing quality-control procedures.

To defend itself in the autism cases, Lilly has turned to the same Kansas City law firm, Shook, Hardy & Bacon, it has used in Prozac wrongful-death lawsuits nationally and in a flurry of drug-tampering cases in Missouri.

Lilly's lawyers will fight the charge that thimerosal, the scientific name for the mercury-based preservative, can cause autism, said Lilly spokeswoman Joan S. Todd.

"No causal link has been established between thimerosal and adverse reactions in vaccines," she said. She criticized trial lawyers in the autism cases for "putting up these Web sites and trying to drum up business."

Lilly scientists developed thimerosal (pronounced thigh-MARE-uh-sol) in the late 1920s and early 1930s and began selling it as a preservative in vaccines in the 1940s. Marketed for some uses under the brand name Merthiolate, thimerosal also has been used as a skin disinfectant and a preservative in blood, cosmetics and cleansers.

Lilly stopped selling thimerosal in 1991 "because it was not a significant source of revenue," Todd said. Lilly hasn't sold childhood vaccines since the 1970s.

Trial lawyers believe Lilly still is liable for damages arising from thimerosal, despite not having sold any for the past 11 years.

"You can't design a product that's lethal and then just step away from it. They made an enormous amount of money on it over the years," Miller said.

Waters, whose firm took the first depositions in the autism cases and may bring the first case to trial early next year, said Lilly also is open to fraud and conspiracy charges, based on evidence he dug up from the 1930s.

Waters charges that Lilly "flim-flammed scientists" for years with a 1931 study that concluded thimerosal wasn't harmful to humans.

The study, published in the American Journal of Hygiene, reported that Merthiolate has "a very low order of toxicity . . . for man."

Digging further, Waters found out the study's toxicity data came from experimental use of thimerosal by doctors from Lilly and Indianapolis City Hospital on meningitis patients during a severe outbreak in 1929-30.

The 1931 study on severely ill people ended up being "quoted in Lilly brochures into the 1980s," Waters said. "It very clearly demonstrates an effort to do an unethical study and then paint the results in a certain way that help them sell this product."

Lilly ignored or covered up later evidence that thimerosal, which contains 50 percent mercury by weight, can be dangerous to humans, Waters said.

Lilly's Todd said the drug firm knows of "two doctors mentioning using this (thimerosal on an experimental basis) in a study in 1929. They were not our doctors."

Waters and other trial lawyers concede that the lawsuits they've filed outpace the state of science on the key question of whether thimerosal causes autism.

"It is uncertain. It is controversial. It's conceivable we won't be able to establish that to the satisfaction of a judge or a jury," Waters said.

He said his firm is carefully picking clients to include only children who suffered autism soon after getting injected with mercury-containing vaccines. The firm also looks for clients who have medical records showing high mercury levels in the child's body.

Experts remain far from convinced thimerosal can cause brain disorders.

"The evidence is inadequate to accept or reject a causal relationship between thimerosal exposures from childhood vaccines and the neurodevelopmental disorders of autism, ADHD and speech or language delay," concluded the Immunization Safety Review Committee of the National Academy of Sciences last year.

As a precaution, the committee recommended the use of thimerosal-free vaccines. It also called for further study of the issue.

The Autism Society of America, the nation's largest autism group for patients and their families, is following the lawsuits but hasn't publicly supported them because the science is unclear that thimerosal causes autism, said Lee Grossman, the society's president.

"If there is a connection . . . why are there millions of children being vaccinated that have not gotten autism?" he asked.

"We just don't know why there's this huge explosion of children being diagnosed (with autism). Vaccines may be part of the issue, but that doesn't seem to explain the tremendous growth in numbers we're seeing. The evidence is still out."

Autism affects 500,000 to 1.5 million Americans and has grown at an annual rate of 10 percent to 17 percent since the late 1980s. That span coincides with the addition of new government-required childhood vaccinations that increased the levels of mercury that children were exposed to, according to lawsuits.

In Indiana, where vaccinations are now required against up to eight diseases before a child may start school, the number of autistic children registered in schools has grown from 116 in 1989 to 3,789 last year.

Burton takes interest

"We have an epidemic on our hands," said Rep. Dan Burton, R-Ind., in a hearing he held on the issue in April as chairman of the Committee on Government Reform.

Burton has publicly suggested thimerosal might be to blame.

The Indiana congressman said his own grandson Christian became autistic shortly after getting a round of childhood vaccinations in his second year of life.

"Shortly after receiving his mandated vaccinations, he became a different child," Burton said at the hearing.

"He no longer spoke. He would not look anyone in the eye. He cried endlessly, banging his head. He began running around flapping his hands. We now know he was suffering from an adverse reaction to his vaccines. We also know that he may have received more mercury in his vaccines than is considered safe by federal standards."

Since 1999, when the FDA and other government agencies warned of potential harm from thimerosal in vaccines, manufacturers have begun supplying doctors with thimerosal-free vaccines, which are now widely used.

Even so, the long use of mercury-containing vaccines left a legacy that could be costly and tragic, said Dr. James J. Bradstreet, director of research at the International Autism Research Center in Palm Bay, Fla., in a report to Burton's committee.

"We must deal with the reality that our vaccine policy exposed a generation of newborns to a neurotoxin -- thimerosal."

Call Jeff Swiatek at 1-317-444-6483.