Federal Officials Consider Liability Issues of Smallpox Vaccine at Issue Briefing
With HHS and the Advisory Committee on Immunization Practices nearing a final decision on a policy for vaccination against smallpox, top health officials have begun discussing liability issues surrounding vaccine-related death or injury (Anthony Wilson, California Healthline, 7/26). HHS officials last month said the agency is considering vaccinating approximately 500,000 health care and emergency workers against smallpox in preparation for a potential bioterrorist attack. In June, the ACIP offered an initial recommendation, saying that the government should provide the smallpox vaccine on a voluntary basis to an estimated 10,000 to 20,000 individuals who would be the first to respond to such an attack (California Healthline, 7/9). Speaking at an Alliance for Healthcare Reform briefing yesterday, D.A. Henderson, the principle science advisor to the HHS secretary for public health preparedness, noted that the smallpox vaccine carries with it a risk of death for between two and four people for every one million vaccinated. Sen. Bill Frist (R-Tenn.), a physician by training, also noted that the smallpox vaccine is not fully tested or approved. Combined with a "likely ... increased risk of bioterrorist attack" and a climate of "skyrocket[ing]" medical liability lawsuits, "smallpox vaccination looks like a great place for a trial lawyer to be in," Frist said. He added, "It's time, from a legislative standpoint, to address vaccine liability."
Frist introduced in March S 2053, the Improved Vaccine Affordability and Availability Act. Among other things, the bill would amend the Public Health Service Act to increase from $250,000 to $350,000 the amount the estate of a person who died as a result of a vaccination would receive. The bill also would bar individuals from bringing civil action against a doctor or vaccine manufacturer for any vaccine-related death or injury. Commenting on possible vaccine-related liability policy from the ACIP, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said, "We can't speak of policy, because it's under discussion. However, there has to be some talk of indemnification" (Wilson, California Healthline, 7/26).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.