Lawmakers on Capitol Hill have voted to provide sweeping new protections against lawsuits to those who make vaccines and other products.
But critics say that the provisions, purportedly aimed at protecting parts of the vaccine industry, are so broad they could prevent injured patients from suing in many cases now covered by product liability laws, including cases involving deaths and injuries due to pharmaceutical products.
President Bush is expected to sign the bill.
The lawsuit provisions were added to the defense spending bill in the dark of night earlier this week.
But they weren't exactly a surprise.
In fact, Senate Majority Leader Bill Frist (R-TN) telegraphed his plans in a speech on avian flu at the National Press Club two weeks ago. "The manufacturers tell us that liability protection is important," Frist said. "So, hopefully, we'll get some liability protection here in the next several days."
Supporters say that the liability protections are intended to encourage companies to develop vaccines against natural threats like pandemic flu, as well as unnatural occurrences such as bioterrorism.
But opponents resisted shielding manufacturers from lawsuits without also guaranteeing compensation to people injured or killed by the products.
"The nightmare scenario I'm concerned about is you start having doctors and nurses refusing the vaccine, and then if that gets in the press, then nobody will take their shots," said Rep. Dave Weldon (R-FL). Like Frist, Weldon is a physician.
Negotiations on the liability provisions have been going on for weeks in both chambers. Then last weekend, the dispute over the compensation provisions led to an impasse in the House.
Late Sunday night, negotiators on the defense bill signed off on the final package without including any vaccine language at all, said House Appropriations Committee ranking Democrat David Obey of Wisconsin.
"The conference committee ended its work with the understanding, both verbal and in writing, that there would be no, I repeat, no legislative liability protection language inserted in this bill," Obey said on the House floor.
But hours after the conference was officially closed, Frist prevailed on House Speaker Dennis Hastert (R-IL) to insert more than 40 pages of legislative language creating the liability shield, in violation of both the House and Senate rules.
"That legislation was unilaterally and arrogantly inserted into the bill after the conference was over," Obey said, adding that it was "a blatantly abusive power play by two of the most powerful men in Congress."
On the Senate side, Frist had been negotiating for days with key senators on the issue. But Sen. Edward Kennedy (D-MA) said what ended up in the bill is far broader than what had been discussed in the negotiations.
Kennedy said the final language in the bill provides "a basic blank check for the industry, not only on pandemic flu, but just about any other kind of, quote, epidemic that anyone can think of."
Under the law, manufacturers would receive the protection from lawsuits when the Secretary of Health and Human Services declares a particular disease as an "epidemic." Already HHS Secretary Mike Leavitt has used the word epidemic in relation to AIDS, obesity, diabetes and chronic diseases in general, potentially broadening the legal protections to many drugs now in existence or under development.
Congress, however, is virtually certain to revisit the issue next year, as it tries to find the other half of the $7 billion President Bush wants for pandemic preparedness. The final bill allocates $3.8 billion for pandemic planning during the current fiscal year.