Newhouse News Service

WASHINGTON DC — A law shielding bird flu vaccine manufacturers from consumer lawsuits could cause many Americans to refuse vaccination for fear they’d have no recourse if it harmed them, some health experts say.

Such a provision, which has been passed by the House and could be voted on in the Senate as early as Wednesday, could significantly undermine efforts to ensure widespread protection against a potential avian flu pandemic, they warn.

Erin McKeon, associate director of governmental affairs for the American Nurses Association, said liability exemptions were partly to blame when other
vaccination programs stumbled.

“Look at how the small pox vaccination program went in 2003, when the president tried to vaccinate half a million health care workers, but really ended up with less than 40,000 because there was no compensation program,” McKeon said.

The liability exemption is attached to a pending defense spending bill. The legislation contains about $3.8 billion to fund strategies for preparing the nation to fight a bird flu pandemic.

Supporters of the liability exemption insist it is necessary to encourage more companies to make vaccine. Vaccine manufacturing is financially risky, drug makers say, partly because the demand for vaccination is transitory. Also, vaccines generally are administered to healthy people who, if they get sick, might blame the vaccine and sue.

Len Lavenda, a spokesman for vaccine maker Sanofi Pasteur Inc. of Swiftwater, PA, said the liability exemption is needed because manufacturers can’t secure liability insurance for bird flu vaccines. Insurers regard such products as uncharted territory, he said.

Without insurance, “We’d be asked to put the company’s entire economic future on the line to produce the vaccine, and we’re not willing to do that,” Lavenda said.

But the Association of Trial Lawyers of America notes that Sanofi Pasteur has signed $100 million in federal contracts to develop bird flu vaccine even though the liability shield does not yet exist. The association said federal health agencies have concluded liability concerns have little or no effect on vaccine production.

Blocking consumers’ rights to take vaccine makers to court would remove an incentive for companies to make safe drugs, the lawyers group said.

Some critics take particular aim at Senate Majority Leader Bill Frist, R-Tenn., for helping to attach the bird flu measure to a must-pass military spending bill late Sunday night. The Foundation for Taxpayer and Consumer Rights maintains Frist is among members of Congress who should not vote on the provision because of conflicts of interest. Frist is one of 42 senators who together owned at least $8.1 million in pharmaceutical company stock in 2004, according to the group’s analysis of public financial disclosure documents filed with the Senate.

“This is a political ploy, to use the possibility of a public health threat to push a long-time agenda of the pharmaceutical industry,” said Carmen Balber, spokeswoman for the foundation, a consumer watchdog group.

Jennifer Page, spokeswoman for the Pharmaceutical Research and Manufacturers of America, said it was “premature” to discuss the provision as it awaits Senate action, but she expressed confidence it would pass.

Efforts to encourage bird flu vaccine development should at least include a federal funding pool to compensate anyone hurt by the vaccine, some experts say. Such a system exists for childhood vaccines, including those for polio, measles and diphtheria, and was adopted for small pox vaccines after so few health workers consented to vaccination.

“It’s a good way to go,” said Randy Pate, visiting health policy fellow at the Heritage Foundation, a conservative Washington think tank.

Doug Heye, spokesman for Sen. Richard Burr, R-N.C., who supports the liability shield, said the legislation would not exempt vaccines from regular safety reviews and would allow vaccine makers to be sued for willful misconduct. Heye said the legislation includes language that would allow government compensation.

But Jeff Levi, senior policy adviser at Trust for America’s Health, a nonpartisan Washington research organization, said the legislation contains no money for such compensation.

“If they really meant to create a compensation fund, this was the place to do it,” Levi said. In the current bill, “There is no meaningful compensation for people who might be affected. This is very broad liability protection.”
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Bruce Taylor Seeman can be contacted at: [email protected]