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.
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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.
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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.
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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."
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