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Smallpox liability bill { November 16 2002 } Original Source Link: (May no longer be active)
http://www.washingtonpost.com/wp-dyn/articles/A61285-2002Nov15.htmlhttp://www.washingtonpost.com/wp-dyn/articles/A61285-2002Nov15.html
Homeland Bill Covers Smallpox Shot Liability
U.S. Would Shield Firms, Health Workers
By Ceci Connolly
Washington Post Staff Writer
Saturday, November 16, 2002; Page A13
The Bush administration, voicing increased fears over the threat of a biological attack, has quietly moved one step closer to a voluntary national smallpox vaccination program by offering full legal protection to manufacturers and medical personnel who administer the vaccine.
A provision belatedly tucked into the homeland security bill, which is now pending before the Senate, eliminates the single remaining major obstacle in a yearlong push to improve the nation's readiness to deal with one of the deadliest viruses in history.
If a smallpox attack is launched, federal health officials aim to vaccinate all 280 million Americans within a week. That effort would take at least 1.5 million volunteers, many of them doctors and nurses employed by private hospitals, clinics or state health departments. A growing chorus of medical professionals warned they would not give the vaccine without guarantees they would not be held liable for the serious, sometimes fatal, complications that can occur.
"This is a huge gap in our response if smallpox hits tomorrow -- and the risk is real," said Sen. Bill Frist (R-Tenn.), a physician who has lobbied the White House to address the liability issues. "Why should a nurse, giving a life-saving vaccine two days after a smallpox attack, as part of a national response plan, be punished if there is a side effect?"
Federal health officials have recommended that prior to any attack the United States slowly phase in smallpox vaccinations, beginning with about 500,000 military and 500,000 civilian health care workers who are considered to be at greatest risk of encountering the virus. After that, they suggest offering vaccine to as many as 10 million first responders and then the entire population some time in 2004.
Several public health experts applauded the effort to hold harmless medical workers but said the administration approach did not go far enough in protecting people who voluntarily get the vaccine.
"Leave it to the Republicans to sneak in a proposal that protects manufacturers of the vaccine, doctors and nurses and leaves the person who may be injured -- even by negligent action -- to bear the whole burden of their injury," said Rep. Henry Waxman (D-Calif.).
Under the administration plan, the federal government would assume all responsibility for the smallpox vaccine. Medical workers administering it would be deemed employees of the public health service and protected under the Federal Tort Claims Act. Smallpox vaccine manufacturers, which were already indemnified under contracts with the Department of Health and Human Services, would receive even broader legal protections.
Patients suffering from harmful side effects such as severe rashes, blindness and encephalitis (inflammation of the brain), would have to sue the federal government for compensation. Individuals would be prohibited from suing any health care provider, medical institution or the vaccine makers -- Wyeth, Aventis-Pasteur and a new joint venture by Acambis and Baxter.
Waxman, state health commissioners and the chairman of the government's vaccine advisory panel all said they preferred creating a no-fault compensation fund to care for people injured by the vaccine.
"A great majority of people who have vaccine-related injuries will not be as a result of negligence," said the committee chairman, John Modlin, a Dartmouth University. "Who is going to pay for their medical costs?"
One top administration health official, who asked not to be named, said he was concerned the questions about compensation could hinder vaccination efforts.
With 15 of every 1 million people vaccinated suffering life-threatening side effects, the ability to sue the federal government did not sound like sufficient incentive to attract volunteers for vaccination, said Oklahoma Health Commissioner Leslie Beitsch.
"We're trying to create an incentive to have an on-the-ground force of public health people ready to go; we want them to do this," he said. "This is hardly an inducement."
In an interview two months ago, Health and Human Services Secretary Tommy G. Thompson said he was considering using the popular Vaccine Injury Compensation program as a model. He was not available yesterday, and aides said it was unclear who would pay to treat serious side effects.
One White House official, speaking on the condition he not be identified, said the tort claims act has successfully handled similar cases in the past. "Few of those cases go to trial," the source said.
© 2002 The Washington Post Company
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