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http://www.nytimes.com/2002/12/14/health/14LIAB.html?tntemail1

For Victims of Vaccine, Winning Case Will Be Hard

By ROBERT PEAR

ASHINGTON, Dec. 13 — People injured by the smallpox vaccine will be able to sue only one defendant, the federal government, and experts who have studied the relevant laws say it will be difficult for anyone to win compensation for injuries or deaths caused by the vaccine.

In the Homeland Security Act, signed by President Bush on Nov. 25, Congress shielded doctors and vaccine manufacturers from liability for injuries suffered by people who take the vaccine. If the federal government authorizes use of the vaccine, the law says, anyone giving or producing it will be "deemed to be an employee of the Public Health Service," and the government will become the only defendant.

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An injured person can pursue compensation under the Federal Tort Claims Act, but lawyers said it would be difficult to win money under that 1946 law.

"The government can probably escape liability for almost all injuries," says an analysis by Prof. Edward P. Richards and Dr. Katharine C. Rathbun of Louisiana State University.

Under the tort claims act, they said, plaintiffs would have to show that the government or people acting on its behalf were negligent in administering the vaccine.

"It would be very hard to recover from the government for risks that the government knew it was exposing people to," said Professor Richards, who is director of the program in law, medicine and public health at Louisiana State. "The government is not liable if it makes a policy choice to expose citizens to risks. It might be a bad policy choice, but it's not negligence."

Dr. Rathbun added, "If everything is done perfectly, without any negligence, some percentage of people given the vaccine will be injured by it — it's a dangerous vaccine — and they will not be compensated under the law."

Health officials estimate that 14 to 52 people of every million vaccinated may face life-threatening injuries, and that one or two will die. But, they say, the risk of serious injuries is much higher among people whose immunity has been suppressed by AIDS, cancer chemotherapy or other illnesses and treatments.

Under the tort claims act, federal employees must observe federal laws and regulations, but generally have no liability for policy decisions or actions performed in an exercise of official discretion.

The litigation process for victims of the smallpox vaccine will differ significantly from that for people injured by childhood vaccines.

In 1986, Congress created a no-fault system to compensate people injured by childhood vaccines. The government reviews and pays claims. The claims are paid from a federal trust fund financed by an excise tax included in the price of each dose of the recommended vaccines. To obtain compensation, a person must show the existence of a vaccine-related injury, but does not have to show negligence.

When the House considered the Homeland Security bill last month, Representative Henry A. Waxman, Democrat of California, said it "severely restricts the ability of persons killed or injured by the smallpox vaccine to receive any form of compensation." In short, he asserted, "if you are hurt, you are out of luck," and "the vaccine manufacturer, for all practical purposes, is going to be immune from liability."

The American Medical Association said today that it supported President Bush's plan to offer smallpox vaccinations to certain health care workers and emergency personnel. But it said that the liability protections, which take effect on Jan. 24, should be in place before doctors start giving the vaccine.

The Service Employees International Union, which represents many health care workers, said the government should establish a "simple and fair compensation system" for people injured by the vaccine. Such a system, it said, should make up income lost by people who become too sick to work after taking the vaccine.

Jim Turner, a spokesman for the Defense Department, said that if active-duty military personnel were injured by the vaccine, they would receive health care through the department's worldwide medical system. If disabled, he said, they could obtain disability benefits and health care from the government.

But military personnel could not sue the government for vaccine-related injuries, even if they believed that the injuries resulted from negligence by members of the armed forces or civilian federal employees. The Supreme Court ruled in 1950 that "the government is not liable under the Federal Tort Claims Act for injuries to servicemen" arising from their military service, and the court has repeatedly reaffirmed this principle, known as the Feres doctrine after the case that established it.

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ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.