The Peanut Allergy Epidemic by Heather Fraser

Author:Heather Fraser
Language: eng
Format: epub
Publisher: Skyhorse Publishing
Published: 2017-05-01T16:00:00+00:00

US Vaccine Injury Act creates liability free environment for vaccine makers

In the spring of 1985, 231 lawsuits were pending in the United States against four vaccine manufacturers.78 Vaccine makers were paying out millions of dollars in settlements, their legal defense costs soared, and insurance was becoming prohibitive. Previously, courts had declared that vaccine makers could not be held strictly liable for selling products “with a known but apparently reasonable risk.”79 The doctors and parents were deemed largely responsible for the risk and any ensuing damage. But as injuries mounted, suits against manufacturers were allowed based on a “failure to warn.” During the flu nonepidemic of 1976, emergency vaccines administered to about forty-five million people over three months were linked to a significant rise in Guillain-Barré syndrome.80 These and other side effects resulted in more than four thousand complaints settled by the US government for $72 million.81

This event opened the door to a flood of vaccine-related lawsuits—cases involving the DPT vaccine escalated from one suit in 1979 to 255 in 1986. Vaccine maker Lederle estimated that total sales of its 1983 polio vaccine were only one-twelfth the value of claims filed against it.82

In this litigious environment many pharmaceutical companies simply abandoned the vaccine market, leaving the US supply in the hands of a few makers. Even the pharmaceutical giant Merck was challenged in 1979 by an internal report questioning their continued presence in vaccine research and development.83 By 1985, the United States was facing a vaccine shortage that threatened public health, declared a report published by the US Institute of Medicine (IOM).84

To reduce the uncertainty faced by manufacturers, the IOM called for the federal government to provide “equitable, rapid compensation in a consistent fashion.” In 1986, President Reagan signed the National Childhood Vaccine Injury Act from which emerged the Vaccine Injury Compensation Program (VICP) in 1988. VICP was a “no-fault” alternative to the tort system in which eligible claims would be determined by a federal court and paid by the federal government.85 Until parents had first exhausted this approach, their tort claims could not proceed. In this new legal environment, the pressures on vaccine makers eased.86 The number of pending lawsuits quickly dropped to just a handful.

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