Compensation plan needed to offset smallpox vaccine risks

Physicians and others have suggested that a federal program be developed to provide no-fault coverage for adverse reactions.

By Susan J. Landers, AMNews staff. Jan. 13, 2003. Additional information

Washington -- It's a given that the smallpox vaccine carries risks for those who receive it, their family members and close contacts. In addition there are legal risks for those who administer it.

Liability and compensation issues still swirl around President Bush's plan for a voluntary vaccination program for members of the military, emergency personnel, physicians and other health care workers.

Although the Homeland Security Act offers protection from liability for doctors who will be providing the inoculations, those protections raise concerns over compensation for those injured by the vaccine.

If private insurers decline coverage because the smallpox vaccine was administered as part of a military action, health care might not even be covered, notes attorney Edward P. Richards, in an online discussion of the vaccine. Richards is the director of the Program in Law, Science and Public Health at Louisiana State University School of Law in Baton Rouge.

American Public Health Assn. Executive Director Georges Benjamin, MD, praises the Homeland Security Act for providing liability protection so the vaccination program can begin, but he also faults the law for failing to provide a compensation mechanism for individuals' costs that could result from the serious adverse reactions associated with the vaccine.

Adequate access to health care for those who have severe reactions to the vaccine needs to be a part of the law, said Dr. Benjamin. "We think Congress still has a little bit more work to do to make sure those things happen."

The Homeland Security Act offers liability protection for physicians who administer smallpox vaccine.

Peter H. Meyers, director of the Vaccine Injury Project at George Washington University Law School, Washington, D.C., thinks Congress has more than a little bit more work to do to make the law fair to those frontline providers who are being asked to volunteer to receive the vaccine.

The liability provisions do provide protection to vaccine manufacturers and those who will be administering it. "They do a great job of that," said Meyers. However, anyone injured by it will have a difficult time recouping damages via a lawsuit, he said.

The homeland security law protects those providing the vaccine by making them federal employees, Meyers explained. Injured parties would be able to file suit under the Federal Tort Claims Act, but they would have to prove negligence. "And there is no reason to think that someone is going to negligently give the smallpox vaccination," Meyers pointed out.

Since past experience has shown that the vaccine will cause injury to at least a small number of people, Meyers said, "it seems to me to be a total outrage for the Bush administration to say, 'OK you can sue us but you have to prove we did something wrong, or somebody was at fault or acted negligently.' "

To avoid this occurrence, Meyers would like to see Congress put in place a safety net for injured people in the form of a program, perhaps modeled on the National Childhood Vaccine Injury Act. That law, passed in 1986, created a no-fault federal system that covers lost income and medical care for those injured by a vaccine.

Such a program could also cover those people who are injured after coming into contact with a vaccinated person, Meyers suggested. That concern looms large for physicians, nurses and other hospital personnel who will be receiving the vaccine.

Many patients will be particularly vulnerable to the vaccine's serious side effects since today's population includes more people with compromised immune systems than when the vaccine was last used in the 1970s.

Physician groups voice concerns

Medical groups are also watching closely. While supportive of President Bush's plan to offer voluntary smallpox vaccinations to health care workers and emergency responders, the American Medical Association has voiced specific concerns.

AMA Trustee Timothy Flaherty, MD, said the Association would be monitoring the data on issues such as adverse reactions, inadvertent transmission to others and the question of medical furlough of vaccinated health care workers. "We are also working with the Dept. of Health and Human Services to ensure that vital federal liability protections are in place prior to the initiation of any smallpox vaccination program."

Experience shows the smallpox vaccine will cause injuries to some people.

As written, liability provisions of the new law would become effective on Jan. 24. It would be up to Congress to provide liability protections if the program begins before that date.

The American Academy of Family Physicians is cautioning its members to be fully informed about the medical and legal issues involved with receiving the vaccine.

The academy states that if individuals or family members have any of the following medical conditions, they should not receive the vaccine unless they are actually exposed to the smallpox virus. Those conditions include: eczema or atopic dermatitis; skin conditions such as burns, chicken pox, shingles, impetigo, herpes, severe acne or psoriasis; weakened immune systems; and pregnancy or plans to become pregnant within one month of vaccination.

Among the legal issues of concern to AAFP are whether the vaccine recipients' health insurance will cover treatment for adverse effects, whether employers will grant paid leave for those experiencing side effects and what liability coverage is provided for the secondary infection of others.

"This immunization program must be closely monitored, and knowledge gained must inform future decisions," said AAFP President James C. Martin, MD.

Meanwhile, the American College of Emergency Physicians has asked the White House to respond to several scenarios. Among them: What if an emergency physician dies from the vaccine? Will his or her family be able to sue for future wages and will physicians who receive the vaccine be treated the same as the people who vaccinate them, for the purposes of tort?

In the armed forces, smallpox vaccinations continued until 1990.

Another question that remains unanswered is the seriousness of the bioterrorism threat and the likelihood that smallpox will be used as a weapon, said Jonathan L. Burstein, MD, director of disaster medicine at Boston's Beth Israel Deaconess Medical Center. "People have been saying, 'well, is there a real risk? You're telling me maybe I should get this vaccine, do I really need to worry?' and the answer is, 'we don't know.' "

Nancy Auer, MD, chair of ACEP's Terrorism Task Force, stopped short of recommending that emergency physicians volunteer for the vaccination. But she said unless contraindications jeopardize the physician, dangers of spreading the vaccinia could be minimized.

"There is information that a good dressing will prevent the spread -- a semipermeable membrane," she said. "A good dressing and good hand washing are going to reduce the risks."

Physicians who were vaccinated as children would probably be the best candidates to volunteer for the upcoming vaccination, said Dr. Auer, who also pointed out that in the armed services, smallpox vaccinations continued until 1990, so some people might still be immune.

"There is a lot of myth and fear that surrounds the smallpox vaccination," she said. "Smallpox is not that easy to catch, but it is contagious. I think the government is trying to ensure that everyone is protected against an unknown risk."

HEALTH & SCIENCE