Critics Say Flu Bill Overprotects Drug Industry

Bird flu preparedness legislation headed for a final vote in the Senate this week would create loopholes that critics said would allow vaccine makers to avoid legal liability even if a patient were harmed by negligence.

Democrats and the Assn. of Trial Lawyers of America derided the provisions Monday as a gift to the drug industry. Supporters of the legal exemption said the lawyers were acting in their own self-interest, but 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 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.”

The provision, backed by Senate Majority Leader Bill Frist (R-Tenn.), 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.

“The question is how high the liability shield needs to be,” said professor Carl Tobias of the University of Richmond School of Law. “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.”

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 the need in an emergency, supporters of the bill said.

Some critics said the language was so broad that 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 provision said emergency legal immunity would only be granted in rare cases, such as an outbreak of a virulent flu or a bioterrorism attack, and would eventually expire. Frist spokeswoman Amy Call disagreed with critics who said the language was 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.”

Call said the drug industry had some input into the legislation but was not totally pleased with its final form.

That any pandemic funding would also include liability protections for vaccine makers was expected. Bush requested it, and Frist promised it. The specific language, which is what drew criticism, 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 process of hearings and committee deliberations.