Bill Would Limit Damages for People Injured by Smallpox Vaccine

By Laura Meckler
Associated Press Writer


WASHINGTON (AP) - Congress is set to deal with one of the stickiest issues in the debate over smallpox vaccinations by giving special legal protection for health care workers who will be delivering the shots.
Experts estimate that 15 out of every 1 million people being vaccinated for the first time will face life-threatening complications, and one or two will die. Health officials say workers will resist giving shots if they can be held responsible for any damage done.

President Bush has yet to announce how many Americans will be offered the risky but effective shots. He met with top bioterrorism advisers Wednesday as he moved closer to a decision.

Health officials favor a plan that would begin by offering the vaccine to people most likely to see a contagious smallpox patient - starting with hospital emergency room workers and special smallpox response teams. Next up would be emergency responders and other health care workers. Eventually, it would be offered to the general public, probably by early 2004.

Others in the White House, including Vice President Dick Cheney, have favored offering the vaccine to the public more quickly, even before the Food and Drug Administration licenses it.

Bush has not said what approach he prefers.

Separately, Bush was considering a Pentagon recommendation to vaccinate U.S. military forces against smallpox. Unlike the civilian vaccination program, which would be entirely voluntary, troops would be required to get the shots.

On Capitol Hill, lawmakers cleared one hurdle for civilian vaccinations.

They added a new provision to the homeland security bill assuring that people or facilities that deliver the inoculations would not face personal liability from lawsuits by people injured or killed by the vaccine. Instead, the federal government would defend any suit and pay any damages. Victims could get compensated for their injuries, but not receive punitive damages.

The homeland security bill passed the House on Wednesday and was headed for a vote by next week in the Senate.

"Because of the risks associated with the smallpox vaccine, many health professionals may be unwilling to give the vaccine without some measure of liability protection," said Sen. Bill Frist, R-Tenn., a leader on bioterrorism issues who has been pushing the liability issue for months. "The threat of lawsuits mustn't be a barrier to protecting the American people."

The liability question touches on the larger issue of tort reform. Tort reform divides Republicans, who generally want to limit lawsuits, from Democrats, who generally want to preserve people's right to sue. But there was little sign of opposition on this provision, which is targeted specifically to the smallpox vaccine.

Smallpox was declared eradicated in 1980, and all stocks of the virus were supposed to have been destroyed except for samples in special labs in Atlanta and Moscow. But experts fear Iraq or terrorist groups have secret supplies of the virus and may release it.

The U.S. population is highly vulnerable to an attack with smallpox, which has no known treatment and historically has killed 30 percent of its victims. Routine vaccinations ended in the United States in 1972, and experts believe those last vaccinated more than three decades ago have retained little if any immunity.

But the vaccine is not without risks. It is 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 spot, often because people touch the spot and then touch their eyes or mouth, or someone else. For instance, the virus transferred to the eye can cause blindness. Other fatal side effects include encephalitis, which can cause paralysis or permanent neurologic damage, and progressive vaccinia, where the virus spreads, eating away at flesh, bone and gut.

Under the provision now part of the homeland security bill, the Federal Tort Claims Act would be extended to any person or facility that provides the vaccine under a plan issued by the federal government. Under this act, cases would be tried in federal court using the appropriate state law.

AP-ES-11-14-02 0136EST


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