Bill would shield Lilly from some lawsuit damages

By Jeff Swiatek

jeff.swiatek@indystar.com

November 16, 2002

A provision in the federal Homeland Security bill could help shield Eli Lilly and Co. from damages in pending and future lawsuits against it for selling a mercury-based preservative put in childhood vaccines.

The legal protection could head off or weaken potentially costly litigation against the Indianapolis drugmaker, which is facing trial next year in the first of more than 45 vaccine preservative lawsuits filed against it.

The lawsuits allege the preservative, called thimerosal, can cause the debilitating neurological condition of autism in some children.

The Republican-drafted bill passed the U.S. House on Wednesday but faces Democratic opposition in the Senate. GOP leaders said the provision was put into the bill to give more legal protections to vaccine makers that might be called on to produce medicines against bioterrorism.

The provision would help Lilly and other companies by extending legal protections already in place for vaccines to vaccine components such as thimerosal, which Lilly developed and sold for more than 40 years.

Currently, under federal law, complaints alleging damage from vaccines are decided first in a federal program set up 14 years ago to help settle claims from injured users of vaccines. Vaccine makers pay into a Vaccine Injury Compensation Fund used to pay damage claims to a maximum of $250,000.

The new provision allows the Lilly thimerosal cases to be decided first by that program, said Lilly spokesman Edward Sagebiel.

Complainants who are unhappy with the program's decision are allowed to reject it and file their action in a civil court.

Sagebiel said Lilly's lobbyists did not seek the special provision in the Homeland Security bill.

"We were as surprised as anyone the language was inserted in the bill," he said. "The company was not actively lobbying to have the language within the bill."

He said Lilly supports the provision as "responsible protection for manufacturers from lawsuits without merit or scientific evidence."

Lilly contends the thimerosal lawsuits are baseless because there is "no causal link" between thimerosal and autism or other conditions, Sagebiel said.

The thimerosal lawsuits began appearing after the federal government in 1999 asked makers of childhood vaccines for measles and other diseases to stop using mercury-based preservatives that were common in childhood vaccines up to then.

Earlier this year, Lilly supported a bill proposed by Sen. Bill Frist, R-Tenn., to extend the vaccine legal protections to vaccine components. A spokesman for Frist's office said Frist did not ask GOP leaders to put the provision in the Homeland Security bill.

Richard Diamond, a spokesman for House Majority Leader Richard Armey, R-Texas, said the provision was inserted into the bill because "it was something the White House wanted."

Diamond said the provision has national security implications. "We put that in there because if these companies are being sued by trial lawyers, they are going to be reluctant to put life-saving medicines on the market" that could be useful against biological attacks, he said.

Dominique Michael, a Virginia attorney who is handling two thimerosal cases against Lilly and vaccine makers called the provision "just awful" because numerous pending thimerosal cases might not meet the statute of limitations in place for vaccine cases.

The federal compensation program requires complaints to be filed within three years of the first symptom of damages from the vaccine, Michael said.

If the three-year limit applies to thimerosal cases, "there are a whole lot of profoundly injured kids out there who aren't going to have a (damage claim) remedy and that's very sad," she said.

Michael questioned whether the provision will in fact protect Lilly, because the federal program only helps defendants who are vaccine makers or those who administer the vaccines. Lilly hasn't made vaccines since the 1970s.

The move to reduce liability for vaccine makers -- whether their shots are used to fight terrorism or not -- brought strong opposition from several Senate Democrats.

They promised Friday to try to take that provision out of the bill and accused Republicans of providing a last-minute reward to the pharmaceutical industry, a major GOP political donor.

"Does this have anything at all to do with homeland security? The answer is no," said Sen. Byron Dorgan, D-N.D. "This is bad legislation."

The Associated Press contributed to this report.

 

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