Legislation that would pour billions of dollars into the production of vaccines against avian flu and other pandemic diseases is threatened by the trial lawyers' lobby, which objects to proposed limits on lawsuits against drug manufacturers.
Republican congressional leaders, acting at the urging of President Bush, hope to approve a measure soon that would appropriate about $7 billion to pay for vaccines that would combat a flu epidemic and biological attacks by terrorists. The bill could begin moving on Capitol Hill this week.
But the Association of Trial Lawyers of America and some of its Democratic allies in Congress are working to scuttle or drastically transform the effort, asserting that anti-lawsuit language in the bill would so broadly indemnify pharmaceutical companies against suits that consumers' rights would be denied.
Sen. Judd Gregg (R-N.H.), the Senate's chief advocate for strict liability protections, asserted that the companies need to be thoroughly indemnified against suits to provide enough of an incentive for them to make vaccines, which tend to be low-profit products.
The conflict will almost certainly lead to fireworks during debate on the floor of the House and the Senate and could delay the legislation itself, which is a Bush priority, lobbyists and congressional aides said.
"A slowdown is possible," said Amy Call, a spokeswoman for Senate Majority Leader Bill Frist (R-Tenn.), who supports strict lawsuit limitations. "That's the way the place works."
Neither side appears willing to bend, and negotiations about the provision lately have been among Republicans only. Democrats are complaining bitterly about being cut out of the process and are working hard to stop the measure.
"The Republican leadership in Congress is trying to do another special favor for 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," Sen. Edward M. Kennedy (D-Mass.) said. "It's cynical to claim that this is what's needed to deal with avian flu."
Sen. Christopher J. Dodd (D-Conn.) said: "We all share the goal of protecting the American people. But I'm alarmed that such a critical question . . . is being handled with a backroom deal."
He and Kennedy also said people might refuse to take a vaccine without an effective compensation program for people who get injured. They asserted that the Republican provision does not contain an adequate plan to compensate such people.
ATLA and its Democratic supporters believe that the pending provision, drafts of which have been circulating informally on Capitol Hill, would stop a wide variety of lawsuits against drugmakers, including those that target drugs other than vaccines. The lobby has long fought such broad restrictions.
Republicans deny that the provision is that far-reaching. But they are also determined to press on with a tough liability provision that the trial lawyers would almost certainly reject. Republican lawmakers and pharmaceutical representatives contend that without strong limits on lawsuits, drug companies will not produce the vaccines.
"You're not going to get vaccine production in the U.S. unless you have liability protection," Gregg said in a telephone interview. "The risk of a major liability suit far outweighs the potential rate of return that you'd get on the investment."
The drug companies, some of which have been working closely with Gregg on the legislation, agreed. "Full liability protection is a requirement for our participation in the development and production of a pandemic vaccine," said Len Lavenda, spokesman for Sanofi Pasteur, the vaccine-making unit of Sanofi-Aventis Group.
Republicans, who are still devising the legislation's liability section, also accuse Democrats of playing politics with public health. "Democrats in the past have always stood up with the trial lawyers," said Call, Frist's spokeswoman. "We'll see if they stand up for them or for the American people."
Contrary to ATLA's assertions, Call said the wording under discussion would affect only companies that manufacture vaccines that counter pandemics officially declared national emergencies.
If the secretary of health and human services certifies such a disaster, she said, patient lawsuits would be restricted to those that claim the companies willfully engaged in misconduct. Lesser allegations would be disallowed as a reason to sue, she said.
ATLA and Republican lawmakers have been sparring for months over how best to deal with lawsuits against vaccine producers. ATLA and its Democratic backers have wanted the language to be narrowly drawn; Republican leaders and pharmaceutical firms have been pushing for wider restrictions.
Republican leaders are considering attaching the latest pandemic provision to any of a several appropriations bills that constitute "must pass" legislation this year. Their options include bills that fund the Department of Health and Human Services and the Department of Defense, staffers said.