Protection for vaccine makers debated

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.

"The Republican leadership in Congress is trying to do another special favor for the drug companies by slipping a provision into a massive spending bill to absolve the pharmaceutical industry of any responsibility to patients injured by dangerous drugs or vaccines, with no compensation for those who are harmed," Sen. Edward M. Kennedy, D-Massachusetts, said in a statement.

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Protection for vaccine makers debated
Legislation would require proof of willful misconduct

WASHINGTON (AP) -- 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.

The measure, which would be included in a spending bill, would bar any punitive damages and limit awards for physical and emotional pain and suffering and other noneconomic damages to a maximum of $250,000.

The draft legislation was provided to the AP separately by two parties opposed to its provisions, who did not want to be identified.

An aide to Sen. Bill Frist, R-Tennessee, confirmed the majority leader was looking to add the liability protections to a spending bill.

Amy Call said the legislation is important because "it would be a pity to appropriate $7.1 billion to purchase vaccines and antivirals but have no capacity to produce them."

She said Frist is seeking clearly defined standards for an industry that is already heavily regulated.

"We would only provide liability protection in a serious situation and for a set period of time and for a specific purpose," Call said. "The protection would only go into effect if the secretary makes a declaration that we are grave danger and the public is advised to take the product."

President Bush's plan for dealing with a flu pandemic called on Congress to give drug manufacturers sweeping immunity against lawsuits. "In the past three decades, the number of vaccine manufacturers in America has plummeted, as the industry has been flooded with lawsuits," Bush said last month. "Today, there is only one manufacturer in the United States that can produce influenza vaccine."

Lawmakers from both political parties also have cited a need to grant the industry some protections. However, the protections described in the draft are quite broad, and some say they would make it extremely difficult for those harmed by a medicine to get any financial compensation.

"The Republican leadership in Congress is trying to do another special favor for the drug companies by slipping a provision into a massive spending bill to absolve the pharmaceutical industry of any responsibility to patients injured by dangerous drugs or vaccines, with no compensation for those who are harmed," Sen. Edward M. Kennedy, D-Massachusetts, said in a statement.

He called for an open debate on the issue.

Sen. Mike Enzi, R-Wyoming, chairman of the Senate's health committee, favors liability protections for drug manufacturers, but not as part of an appropriations bill, according to spokesman Craig Orfield.

"He does not want to address biodefense in a piecemeal fashion," Orfield said.

Trial lawyers said they oppose having to prove "willful misconduct" to get financial compensation from an injury.

"Basically, as an average person, I would have to prove some scientist at Merck or some CEO somewhere had made a determination to hurt me," said Chris Mather, a spokeswoman for the Association of Trial Lawyers for America.

Willful misconduct, according to the draft legislation, would occur if manufacturers or distributors of a particular product knew that it presented "a significant or unreasonable risk to human health" and there was a "conscious failure to act" to avoid that risk.

If the HHS secretary rules against the petition, then those claiming to be harmed could seek judicial review from the U.S. Court of Appeals.

Rep. Dave Weldon, R-Florida, a doctor who said he is involved peripherally in the talks, said he doesn't want protections so broad that people might be unwilling to take medicine in the event of a flu pandemic.

"The way it's being discussed is lacking," Weldon said.

Meanwhile, House GOP leaders have delayed until December any action on President Bush's $7.1 billion request to prepare for a potential bird flu pandemic. The development came as negotiators on a huge spending bill covering health care and education programs met Monday night.

The House rejected an almost $8 billion Senate plan to fight the flu, saying it will revisit the issue next month as it also turns to Bush's request to direct emergency funds already enacted for victims of Hurricane Katrina to new purposes such as rebuilding highways, levees and federal facilities damaged by the storm.

Copyright 2005 The Associated Press.
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