Monday, December 19, 2005

News - Bird-Flu Bill Slammed as Loophole for Drugmakers - Los Angeles Times

WASHINGTON ? Bird flu preparedness legislation headed for a final vote in the Senate this week would create loopholes allowing vaccine makers to avoid legal liability even if a patient is harmed by negligence, critics said today.

Democrats and the Assn. of Trial Lawyers of America derided the legislation as a gift to the drug industry, but its supporters said the lawyers were acting in their own self-interest. Nonetheless, a leading public health group also criticized the liability language.

"We recognize the need for liability protections to get the industry into the game, but we're uncomfortable with the breadth of the liability protections and the fact that they are not balanced by an appropriately strong compensation program," said Jeffrey Levi, a policy advisor with the Trust for America's Health, which advocates stronger government action to deal with the threat of a flu pandemic.

The liability provisions are contained in a mammoth defense spending bill that would also provide $3.8 billion of President Bush's $7 billion request for pandemic preparedness.

"Washington Republicans tucked a huge Christmas present for the drug companies into the appropriations bill in the dead of night," said Rep. Henry A. Waxman, D-Los Angeles. "The liability shield can be granted to any product used to prevent or treat an epidemic or a pandemic, and the (administration) gets to decide what that means."

Backed by Senate Majority Leader Bill Frist, R-Tenn., the provision would allow the government to extend legal immunity to vaccine and drug makers by declaring a public health emergency.

Manufacturers of drugs designated to deal with the emergency would be shielded from lawsuits unless they had engaged in "willful misconduct." Such a threshold is so high it would protect companies that were negligent or reckless, critics said.

Although the legislation would create a compensation program for patients injured by pandemic vaccines, it allocates no money for the fund. That would be determined according to need in a given emergency, supporters of the bill said.

Some critics said the language is broad enough it could allow the secretary of Health and Human Services to declare an emergency for any serious health problem facing the country, such as obesity or diabetes. The bill specifies that the secretary's decision could not be challenged in any federal or state court.

Backers of the legislation said emergency legal immunity would only be granted in extremely rare cases, such as an outbreak of highly virulent flu or a bio-terrorism attack, and would eventually expire. Amy Call, Frist's spokeswoman, disagreed with critics who say the language is overly broad.

"It is very targeted," she said.

"The trial lawyers apparently would prefer to keep filing frivolous lawsuits and collecting excessive attorney fees rather than making sure public health is protected," she said.

Call said the drug industry had some input into the legislation, but was not totally pleased.

That any pandemic funding would also include liability protections for vaccine makers was widely expected. Indeed, Bush requested it. The specific language was added at the last minute at the request of Frist and House Speaker J. Dennis Hastert, R-Ill., said a Republican staffer involved with the bill.

Such provisions are sometimes called "midnight riders," because they are not vetted through the full process of hearings and committee deliberations.

"This is another midnight rider that should never be given the chance to ride," said Sen. Edward M. Kennedy, D-Mass. "This outrageous provision has nothing to do with protecting our troops, and should be struck from the bill."

Odds of that happening are considered slim. But the Senate should revisit the issue, said professor Carl Tobias of the University of Richmond School of Law. "The question is how high the liability shield needs to be," Tobias said. "I think 'willful misconduct' is too high. We usually use some kind of negligence standard in these situations. It would be very unusual that you could prove that intentional misconduct had happened."

Bird-Flu Bill Slammed as Loophole for Drugmakers - Los Angeles Times

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