NCPA - National Center for Policy Analysis


October 19, 2007

The birth of "liability without fault" in pharmaceutical litigation in 1958, set the dangerous precedent that vaccine companies would be held liable for side effects even when their products were made using the best available science and according to government regulations, says economist Paul Howard.

Vaccine litigation exploded in the 1980s:

  • In 1983, Lederle estimated that its diphtheria, tetanus, and pertussis (DTP) vaccine sales were "dwarfed by legal claims by 200 to 1."
  • In 1984, the first-ever million dollar vaccine jury verdict came down against a DTP vaccine manufacturer, later followed by a $10 million verdict against a polio vaccine manufacturer.
  • Litigation took a deadly toll on vaccines; in 1957, there were 26 vaccine makers but, by the mid-1980s, there were just four.

In 1986, Congress intervened to create the Vaccine Injury Compensation Program (VICP), which substituted a science-based, administrative compensation system for injuries suffered from childhood vaccines (other vaccines have since been added).  The program has brought the industry back from the brink, but thimerosal (a mercury-based preservative in vaccines) litigation is threatening to sink it yet again.

Since 2001, about 5,000 families have filed thimerosal-autism claims against VICP, forcing the program to lower its standards for evaluating claims.  According to Newsweek, "autism plaintiffs are no longer required to file medical records with their claims, because VICP clerk's office does not have the space to accommodate such massive amounts of paper."

VICP claims have been consolidated into a handful of test cases before the U.S. Court of Federal Claims.  In these "vaccine courts" claimants just have to meet a civil claims standard of "preponderance of evidence, showing that causation is 'more likely than not.'" If the plaintiffs win, the VICP program -- with only $2.5 billion in reserves -- could be bankrupted, says Howard.

Source: Paul Howard, "On Vaccines, Immune to Reason," Washington Post, October 12, 2007.

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