Vaccine history shows need to update VICP law
By Dr. Paul Offit

On April 12, 1955, Thomas Francis stood on a podium at the University of Michigan and declared that Jonas Salk’s polio vaccine — made by inactivating poliovirus with formaldehyde — was safe and effective. Church bells rang across the country, factories observed moments of silence, synagogues and churches held special prayer meetings, and parents and teachers wept. "It was as if a war had ended," recalled one observer.

But two weeks after the release of the vaccine, the federal agency responsible for its regulation received a series of telephone calls about a strange outbreak of paralysis in children in California. In each case paralysis occurred in the arm that was inoculated with Salk’s vaccine, and in each case the vaccine was made by Cutter Laboratories. Cutter’s vaccine was immediately recalled, but 380,000 doses had already been administered — mostly to healthy first- and second-graders.

Within months, the Communicable Diseases Center in Atlanta found that Cutter’s vaccine had caused 70,000 cases of mild polio, 200 cases of permanent paralysis and 10 deaths. It was one of the worst pharmaceutical disasters in American history.

Two years after the tragedy, Melvin Belli filed the first lawsuit against Cutter Laboratories, on behalf of Anne Gottsdanker, a 5-year-old girl whose right leg was paralyzed by Cutter’s vaccine. Belli sued Cutter on two counts: negligence (that it failed to exercise ordinary care in the production of its vaccine) and breach of implied warranty (that it was implied that a vaccine labeled inactivated polio vaccine did not contain live poliovirus).

The jury was shown two pieces of evidence that determined the verdict: (1) all five companies had difficulties completely inactivating poliovirus, and (2) Wyeth Laboratories also made one lot of vaccine that paralyzed and killed several children in the Northeast.

Apparently, polio-vaccine manufacturing had not yet evolved to the point where tens of millions of doses could be produced safely. Realizing that manufacture of the polio vaccine was still a process in evolution, the jury found that Cutter Laboratories was not guilty of negligence but was guilty of breaching an implied warranty.

For pharmaceutical companies, liability without fault was born.

By no longer requiring proof of negligence, it was easier for juries to find pharmaceutical companies liable. Decisions about harm now rested solely on the jury’s capacity to understand the science of cause and effect.

Unfortunately, jurors have been poor arbiters of scientific truths.

For example, although clearly refuted by epidemiological studies, the courts ruled that silicone-filled breast implants caused connective-tissue diseases (a ruling that resulted in a settlement of $4.25 billion) and that Bendectin, a drug for morning sickness, caused birth defects (a ruling that drove a safe and effective product off the market).

Initially, vaccines were unaffected by the Gottsdanker verdict. But in the late 1970s and early 1980s lawyers in the United States successfully sued vaccine makers claiming that the pertussis (or whooping cough) vaccine caused permanent brain damage despite a series of studies at variance with those claims. To meet the demand for increased liability insurance, the cost of the pertussis vaccine increased from 17 cents to $11 per dose and the number of companies making it decreased from eight to one. Vaccines — a medical intervention that had increased the lifespan of Americans in the 20th century by 30 years — were the first medical product about to be eliminated by lawsuits.

In 1986, to ensure the continued participation of pharmaceutical companies in the manufacture of vaccines, Congress passed the National Childhood Vaccine Injury Act, at the center of which was the Vaccine Injury Compensation Program (VICP). Funded by a federal excise tax on every dose of vaccine, the program insured that all individuals harmed by vaccines were compensated quickly, generously and fairly while at the same time protecting vaccine makers from abuses by the tort system. "Vaccine court" consisted of scientists, epidemiologists and clinicians with a wealth of expertise and experience in vaccines and vaccine safety.

Unfortunately, the VICP, now 20 years old, is showing its age and the viability of vaccines is again threatened. For example, plaintiffs can always opt out of the program and take their cases to court.

Litigation is now building claiming that thimerosal, present in many vaccines before 2001, caused autism. Although the contention that thimerosal caused autism is refuted by four large epidemiologic studies, vaccine makers have spent $200 million dollars defending against these lawsuits and are again bracing for settlements or awards that could threaten their desire to remain in the vaccine business.

Further, concerned about letting juries decide the science of cause and effect, pharmaceutical companies are balking at making a pandemic influenza-virus vaccine without liability protection.

Given the importance of vaccines to the public’s health, we must strengthen the VICP by disallowing an "opt out" of the program (such as is the case with thimerosal litigation) as well as by extending the program to include a vaccine against pandemic influenza. Otherwise, in the name of "consumer protection," we will be hurting consumers far more than we will be helping them.