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"Protecting the health and informed consent rights of children since 1982."

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NVIC Note: The Third International Public Conference on Vaccination to be held Nov. 7-9, 2002 at the Crystal Gatway Marriott Hotel in Arlington, VA near Reagan National Airport will feature speakers talking about smallpox vaccine, bioterrorism and public health laws as well as the federal vaccine injury compensation program and civil litigation. Come and hear why the vaccine injury compensation program created by Congress in 1986 should not be a model for future federal compensation programs because it is not fair to vaccine victims. At the conference you will learn why protecting the right to seek justice in the civil courts when drug companies have not done all they could to ensure the safety of their products is so important.

THE NEW YORK TIMES

U.S. May Limit Suits Over Smallpox

October 24, 2002

By THE ASSOCIATED PRESS

Filed at 7:28 a.m. ET

WASHINGTON (AP) -- The Bush administration is preparing to

ask a lame-duck Congress to address one of the stickiest

issues in the smallpox vaccine debate: how to compensate

people who are injured or killed by the vaccine itself.

One option is a large fund that victims who develop serious medical problems could tap into, modeled after an existing compensation fund for childhood vaccines. Another approach would be to protect nurses and other health workers who administer the shots from lawsuits without setting aside money for compensation.

Administration officials say the issue must be resolved

before the government begins offering the effective but

risky vaccine in an effort to protect people from a disease

not seen for decades but feared as a bioterror agent.

``A number of health care workers and volunteers would

simply not be willing to give the vaccine without some sort

of liability protection,'' said Sen. Bill Frist, R-Tenn.,

who has been pushing for a resolution to this issue.

Congress does not return to Washington until the week after

the Nov. 5 elections.

Officials estimate that 15 people will face

life-threatening injuries for every million vaccinated, and

one or two will die.

Frist said nothing can move during the limited lame duck congressional session without bipartisan agreement. And anything that limits the right to sue could be controversial, he said.

President Bush also could handle the liability issue administratively, officials said. That would involve drafting people who administer the vaccine into the National Health Service Corp., which could protect them from lawsuits under the Federal Tort Claims Act.

But that would do nothing to protect hospitals or other facilities where the vaccine is delivered, Frist said. Plus, there are logistical hurdles to drafting so many people into the corps, especially if vaccination is being administered on an emergency basis in response to an attack.

Top federal health officials have recommended making the vaccine available to people in stages, beginning with people who work in hospital emergency rooms, then to other health care workers and emergency responders and finally to the general public.

The White House is still considering how quickly to move, whether to wait until the vaccine is licensed or offer it more quickly. Beyond those questions, the liability question is the only major unresolved issue, officials say.

Most of the fear surrounding smallpox is about the disease

itself: It is highly contagious, has no known treatment and historically has killed 30 percent of its victims. While it was declared eradicated from earth in 1980, experts fear that Iraq or terrorist groups may secretly have the smallpox virus and unleash it in an act of germ warfare.

Routine vaccinations ended in the United States in 1972,

and experts believe that those last vaccinated more than

three decades ago have little residual immunity remaining.

But the decision to offer the vaccine is a difficult one because the vaccine itself is so dangerous. It's made with a live virus called vaccinia that can cause serious damage both to people vaccinated and to those with whom they come into close contact.

The most common serious reaction comes when vaccinia

escapes from the inoculation site, often because people

touch the site and then touch their eyes or mouth or

someone else. For instance, the virus transferred to the

eye can cause blindness.

More deadly is encephalitis, which can cause paralysis or permanent neurologic damage. Also fatal: progressive vaccinia, where the virus spreads, eating away at flesh, bone and gut.

People would be told the risks before they are vaccinated.

Still, officials are considering how to compensate people

who get the shots and are injured.

Under one plan, Congress would bar lawsuits and, instead, establish a federal fund to compensate injured patients, according to two officials involved in the smallpox vaccine planning. It's unclear how much money would be needed or how much each injured person would be entitled to, they said Wednesday, speaking on condition of anonymity.

It could be modeled on the National Vaccine Injury

Compensation Program, which gives money to people who are injured by a variety of childhood and other regularly administered vaccines.

Another option, Frist said, is for Congress to extend the Federal Tort Claims Act to those involved in smallpox vaccinations. Under this approach, the federal government would defend any lawsuit brought and pay any damages. The case would be tried in federal, not state, court, and be heard by a judge not a jury, he said. In addition, there could be a ban or limit on punitive damages.

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