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tion summarizing what most babies who receive vaccines with a whole- should be protected from vaccine injury law-
cell pertussis component are likely to experience. Short-term reactions suits. As a result, the Ninety-Ninth Congress
that affect 50 to 80 percent of infants include fever, pain and redness at passed the National Childhood Vaccine Injury
the injection site, as well as irritability and loss of appetite. More severe Act (NCVIA), signed into law by President
reactions include high-pitched screaming, hypotonic-hyporesponsive Ronald Reagan in 1986. 12,13 The goal of the
episodes (HHEs), seizures and brain swelling (encephalitis, encephalo- NCVIA was to restrict lawsuits against vaccine
myelitis or encephalopathy). Fisher further explains, “Between 25 and manufacturers by creating a no-fault alternative
60 percent of children who develop acute encephalitis or encephalopathy to the traditional tort system.
or have convulsions, including febrile convulsions. . . are left with. . . Fisher and NVIC’s co-founders worked to
personality changes, developmental delays and learning disabilities, secure vaccine safety and research provisions
ADHD [attention-deficit/hyperactivity disorder], seizure disorders, lower in the historic law, which included a number
IQ, speech, motor and behavior disorders and other disabilities.” of regulations related to informed consent and
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For over a decade after her son’s injury, Fisher and other parents adverse event reporting. As a result of their ef-
worked tirelessly to get the purified, less reactive diphtheria, tetanus and forts, for the first time “Congress acknowledged
acellular pertussis (DTaP) vaccine licensed in the United States. The U.S. the reality of vaccine injuries and deaths, that
Food and Drug Administration (FDA) approved the first DTaP vaccines in safety reforms [were] needed, and that those
1991—but only for use in children fifteen months to six years of age and who are harmed by vaccines should be finan-
only following the administration of three earlier doses of the whole-cell cially compensated.”
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DPT vaccine! It was not until 1996 that the agency approved the acellular Within a year of the 1986 Act’s passage,
vaccine for use in infants and children for all five of the recommended in December 1987, medical trade association
doses of diphtheria, tetanus and pertussis vaccination, and it was not lobbyists persuaded Congress to quietly add
until 1997 that the Centers for Disease Control and Prevention’s (CDC’s) an amendment to the Act, which gave civil li-
Advisory Committee on Immunization Practices (ACIP) recommended ability protection to doctors and other vaccine
DTaP instead of the whole-cell versions. It had taken fourteen years of administrators. In 1988, HHS began to imple-
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consumer advocacy by parents of DPT-vaccine-injured children to secure ment the National Vaccine Injury Compensation
a less reactive vaccine for America’s babies. Program (NVICP) that was established under
Today, most African countries and many other developing countries the 1986 Act. The program is funded by a tax of
as well as one European country (Poland) still use whole-cell DTP vac- seventy-five cents collected per dose of vaccine
cines, in part because they are much cheaper to manufacture. In contrast, administered.
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Japan began using acellular DTaP vaccines in 1981 and immediately Although Congress promised that the
began observing far fewer serious reactions. NVICP would be a “non-adversarial, expedited,
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less traumatic and less expensive administra-
THE END OF LIABILITY tive alternative” to lawsuits against vaccine
Case histories of DPT vaccine injury and death had appeared in pres- manufacturers, this has not turned out to be the
tigious medical journals for more than fifty years prior to Fisher’s family case. According to Fisher, by 1995 the NVICP
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tragedy, but it was not until the mid-1970s that people began to sue U.S. instead not only additionally shielded doctors
vaccine manufacturers for injuries and deaths caused by the extremely from liability for vaccine injuries and deaths
reactogenic whole-cell pertussis vaccine. Most often, the DPT vaccine but was moving toward becoming an “exclusive
seemed to affect young children like Fisher’s son, causing permanent legal remedy that prohibited all product liabil-
brain damage or even death. As the number of lawsuits brought against ity against vaccine manufacturers.” In fact,
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vaccine makers increased dramatically through the 1970s and 1980s, then-HHS Secretary Donna Shalala, along with
vaccine manufacturers paid out millions of dollars to victims and their officials at the CDC and attorneys in the U.S.
families, primarily in financial settlements reached outside the courtroom, Department of Justice (DOJ), actively worked to
settlements that required all case documents to be sealed from public weaken the NVICP’s compensation and safety
view as a condition of the settlement. provisions.
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In this environment of litigation, pharmaceutical companies manu- After these parties pushed through amend-
facturing vaccines threatened to exit the childhood vaccine business ments to the NVICP in 1995, the only events
and effectively blackmailed Congress into providing them with liability considered to be associated with DPT vaccina-
protection, alleging that if the federal government licenses and recom- tion were anaphylaxis (a serious and potentially
mends—and state governments mandate—vaccines, manufacturers fatal allergic reaction) occurring within four

WINTER 2020 Wise Traditions 71