U.S. may limit suits over smallpox injuries or death

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http://www.miami.com/mld/miami/news/nation/4355733.htm

Posted on Thu, Oct. 24, 2002

U.S. may limit suits over smallpox

LAURA MECKLER

Associated Press Writer

WASHINGTON - 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.