Protection for vaccine makers debated

AP: Dr. Frist Sneaks Immunity For Drug Companies Into Spending Legislation...

People injured by a vaccine against bird flu or anthrax would have to prove willful misconduct to bring a claim for damages against drug manufacturers or distributors, according to legislation being drafted behind the scenes by Republicans.

A 10-page draft of the legislation obtained by The Associated Press says it would be up to the Health and Human Services secretary to declare that such misconduct occurred. If that declaration is made, the case must be heard in federal court.

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Forced To Withdraw Drug Company Immunity From 2002 Homeland Security Bill After Outcry...

Under pressure to undo what they had done in secret, congressional Republicans agreed Friday to eliminate special-interest provisions in last year's homeland security bill, including language that would have protected pharmaceutical companies from lawsuits stemming from certain vaccines.

Under the agreement, drug manufacturers such as Eli Lilly no longer will enjoy limited liability for mercury-based vaccines that are the target of lawsuits by parents of autistic children.
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Discovery of these special provisions caused an uproar that almost sank the homeland security bill in November. Democrats and moderate Republicans threatened to vote against the bill if they weren't removed.

Republican leaders salvaged the bill as the final vote was under way, promising Republican Sens. Lincoln Chafee of Rhode Island and Olympia Snowe and Susan Collins of Maine that the offending language would be removed by this session of Congress.

"The 11th hour addition of these special-interest provisions in the homeland security bill was both egregious and unacceptable," Snowe said Friday. Collins called the agreement "a victory for fairness."

...The vaccine provision caused the biggest furor, because it was designed to protect vaccine makers from lawsuits targeting thimerosal, a preservative containing mercury that until two years ago was used to store children's vaccines. Parents of autistic children have sued vaccine makers, saying the thimerosal may have contributed to the condition. Scientists have not established a clear link between the two.

Republicans added the provision to encourage pharmaceutical companies to produce vaccines that could thwart biological attacks. The idea was that fear of lawsuits could create a chilling effect that would reduce the number of vaccines available. But by making the provision retroactive, the law threatened to knock thousands of parents' lawsuits out of court.

The most obvious beneficiary of the provision is Eli Lilly, an Indianapolis-based company that manufactured thimerosal more than two decades ago. Eli Lilly lobbied for the lawsuit protection, but has said it played no part in putting it into the homeland security bill.

Within a week of President Bush's signature on the homeland security bill, an Oregon judge dismissed three lawsuits against Eli Lilly, citing the new liability provision.

Michael Williams, a lawyer representing the families of autistic children, said eliminating the provision might permit him to refile the cases. But he said he didn't know whether the statute of limitations on filing the suit might have run its course.

Republicans agreed to consider broader vaccine legislation within six months that would include liability protections as well as incentives to produce new vaccines.

In a statement Friday, Eli Lilly said it was disappointed by the agreement, but that it would seek to incorporate the eliminated provision in new vaccine legislation.