Liability protection given for smallpox vaccinations, but many worries remain

Lawsuits seem unlikely, but some still left uneasy about plan

Questions still remain about the plan to vaccinate some health care workers against smallpox as health care leaders debate the safety of the vaccine, how it will worsen the shortage of personnel, and its potential liability concerns. Some of these questions may remain unanswered for weeks or months after the vaccinations.

For risk managers, a prime concern is the potential for lawsuits from health care workers adversely affected by the vaccine. Risk management leaders are monitoring the liability issues and many say there is little to worry about. Smallpox vaccinations can be handled pretty much like any other vaccinations for health care workers, says Michael Seitz, vice president for risk management with Fairview Healthcare Services in Minnea-polis and a board member of the American Society for Healthcare Risk Management. Vaccinations are common in health care settings, and Seitz says the same policies and precautions should apply.

Gina Pugliese, RN, MS, vice president of the Premier Safety Institute in Chicago and a risk manager, agrees that there is no reason to fear the smallpox vaccination plan as an unusual liability risk. Nevertheless, the vaccination plan will be a major endeavor for any hospital, and she says the risk manager should participate in any multidisciplinary committee that makes key decisions about the vaccinations.

Though both risk managers are confident that smallpox vaccinations should not pose an unusual liability risk to health care providers, they also allow that some questions can’t be fully answered until the vaccinations have taken place and complications appear.

"We’ll have to see if the plaintiff’s bar finds a way to pursue some of these issues," Seitz says. "We’ve been surprised before by the creativity of some attorneys."

Federal protections cover most scenarios

The protection offered by recent federal legislation seems to rule out most lawsuits aimed at health care providers who administer the smallpox vaccine. Without stringent federal protection, the American Medical Association (AMA) considers lawsuits a real possibility and wanted federally backed liability protections in place before initiation of any smallpox vaccine program. The AMA’s House of Delegates voted to request initiation of the liability program before starting vaccinations, pushing for an earlier implementation of a provision of the Homeland Security Act. That act was approved by Congress and signed by President Bush in November. It included liability protections but the coverage wasn’t slated to take effect until Jan. 24.

In the Homeland Security Act, Congress shield-ed health care providers and vaccine manufacturers from liability for injuries suffered as a result of the smallpox vaccination by stating that anyone giving or producing the vaccine will be "deemed to be an employee of the Public Health Service." That makes the government the only defendant who can be sued for injuries. The plaintiff would have to sue for compensation under the Federal Tort Claims Act. Under that act, federal employees — a definition that includes anyone administering the vaccine — must observe federal laws and regulations but they generally have no liability for policy decisions, or actions performed in "an exercise of official discretion."

Experts say those limitations would make any vaccine lawsuit a tough case to win. And even a successful case would have plaintiffs digging into the pockets of Uncle Sam, not the hospital or other health care provider who administered the vaccine. The likelihood of a successful smallpox lawsuit is slim, even worse than a plaintiff suing for injuries from a childhood vaccine, experts say. Congress created a no-fault system in 1986 to compensate people for injuries from childhood vaccines, but the hurdles are much smaller than one would face with the current smallpox vaccinations. For injuries from the childhood vaccines, the government reviews and pays claims using a special tax imposed on the vaccines. Plaintiffs only need to show that the vaccine injured them; it is not necessary to prove negligence.

The protection in the Homeland Security Act applies to vaccine manufacturers as well as to physicians and other providers who administer the vaccinations, but the AMA also is calling for protection for those injured from the vaccine. The AMA statement says, "A simple and fair compensation system — like the federal Vaccine Injury Compensation Fund — should be made available to assist anyone who is injured from receiving the vaccine or coming into contact with someone who received it."

Jerome Hauer, assistant secretary at the Health and Human Services Department and an expert on emergency preparedness, addressed the issue at a recent news conference and said the government is considering providing such protection.

"We looked at the liability issue," he said. "It is clearly a key component of this program. I hope to get that resolved in the very near future."

Furloughs not necessary, CDC suggests

Concerns over the risk to health care workers has created resistance among some groups to the vaccination plan, including a harsh response from the 1.5 million-member Service Employees International Union (SEIU), the nation’s largest health care workers’ union.

"President Bush’s smallpox plan puts hospital workers and their patients at unnecessary risk," says Andrew L. Stern, SEIU president. Stern says the vaccine is risky for one in six Americans who are pregnant, suffer from eczema or other skin disorders, or whose immune systems are suppressed because of conditions such as HIV, cancer, or transplant treatments. "However, Bush’s plan fails to provide free, confidential screening for those conditions before workers or the public are given the vaccine. It also does not do enough to safeguard vulnerable patients who could come into contact with the 500,000 hospital workers being asked to volunteer for the vaccine."

Diane Sosne, RN, national co-chair of the SEIU nurse alliance, says, "Health care workers want to be able to care for patients if a smallpox outbreak occurs, but it is wrong to put caregivers, their patients, and their families at risk when there is a safer way."

After health workers receive the vaccine, the Bush plan calls for millions of firefighters, police, and other "first responders" to be vaccinated. In about a year, the vaccine will be offered to the public. SEIU has asked the president to monitor the initial volunteers who receive the vaccine, track their response, and make that information available so the public can make an informed decision about whether it wants to receive the vaccine.

Concerns over the risk to health care workers have prompted some hospitals to opt out of the smallpox vaccination plan. Grady Memorial in Atlanta and Virginia Commonwealth University in Richmond both say the vaccine risks outweigh the need to protect health care workers. Carlos del Rio, MD, chief of medical services at Grady Memorial and a professor of infectious disease, says hospital leaders decided not to participate in the smallpox vaccination plan because the vaccine carries too much risk for individual health care workers. At Virginia Commonwealth, Hermes A. Kontos, MD, chief executive of the University’s health system, cites similar reasoning. The threat of a terrorist attack using smallpox is not great enough to justify the complications of the vaccine, he says.

Participation is not mandatory and the scale of the vaccinations will vary for each health care provider. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended smallpox immunization for 510,000 health care workers, saying each hospital should designate a smallpox care team that will be immunized first. That team should include about 40 health care workers per hospital, including the epidemiologist, infection control staff, 15 emergency department (ED) physicians and nurses, eight intensive care unit (ICU) nurses for adult patients, eight pediatric ICU nurses, one infectious disease consultant, one dermatology consultant, four respiratory therapists, four radiology technicians, two engineers, and selected staff from the security and housekeeping departments.

That core team should be able to respond to the first cases of a smallpox outbreak without exposing health care workers unnecessarily, says Jane Siegel, MD, who advised ACIP on the issue as a member of the CDC’s Healthcare Infection Control Practices Advisory Committee. Individual hospitals are free to decide the exact makeup of the team.

At the same time the liability question was being debated, hospitals still were waiting for a CDC decision on medical furlough for vaccinated workers. Some smallpox experts have suggested that workers be furloughed to prevent them from spreading vaccinia, the virus used in smallpox shots. The CDC estimates that 30% of those who are vaccinated will feel too sick to work and provide proper patient care for one or more days. Ten percent might have a more serious reaction.

The CDC downplays the risk of transmission, suggesting that furloughs are not necessary. In a press briefing at the CDC, John Modlin, MD, chair of the ACIP, said workers could continue to care for patients after receiving the vaccine. It is sufficient to cover the vaccination site with absorbent material such as gauze and at least a single layer of impermeable acoustic dressing until the scab separates, he says. His committee recommends against placing health care workers on leave after receiving smallpox vaccination unless they develop symptoms from the vaccination or do not adhere to infection control precautions.

Modlin explained that "the very close contact required for transmission of vaccinia to household contacts is unlikely to occur in the health care setting.


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