Comments:  (UPDATED) According to North Carolina Lawyers Weekly, there is no record of a liability lawsuit involving a flu vaccine manufacturer litigated in North Carolina by Democratic presidential candidate (and former trial lawyer) John Edwards.

As I wrote before that information became available, it's a moot point anyway, given that knowledgeable sources do not attribute the current U.S. vaccine shortage to litigation, "frivolous" or otherwise.

As the email correctly states, the immediate cause of the shortage was a halt in production by Chiron Corp., one of the two main suppliers of flu vaccine to the United States, after contamination was discovered at its newly-purchased Liverpool, England plant. Authorities revoked the company's license, leaving the U.S. approximately 40 percent short of its planned stockpile of 100 million doses for the year.

Chiron is an American company, however, not a British one. Its headquarters are in Emeryville, California. The other primary U.S. supplier, Aventis Pasteur, is a French company which manufactures its flu vaccine in Pennsylvania.

High-risk, low-profit, labor-intensive

While it's true that there used to be more U.S.-based pharmaceutical companies making influenza vaccines, it isn't necessarily true that the ones who stopped did so because they feared litigation. The fact of the matter is that, compared to manufacturing drugs or other types of vaccine, producing flu vaccine is an exceedingly high-risk, low-profit, labor-intensive enterprise. Pharmaceutical companies have dumped the product because, in the words of a recent Washington Post article, it "has simply become too much trouble." Liability costs, real or potential, comprise only part of an economic equation which also includes such factors as government regulation (including price controls), market unpredictability and production challenges unique to flu vaccines. For perspective, according to data published by the U.S. Health and Human Resources there were only two lawsuits filed per 10 million doses of flu vaccine between 1990 and 1995 — a ratio the Raleigh News & Observer called "minimal" in an article published October 29.

Twenty years ago, liability lawsuits did contribute to the withdrawal of manufacturers from the market and national vaccine shortages, government sources confirm, but the industry's burden of risk was significantly reduced from the late 1980s on by the enactment of the Vaccine Injury Compensation Program, which provides alternatives to litigation.

Sources and further reading:

Flu Shots: What You Need to Know
Associated Press, 21 October 2004

Shortage in Flu Vaccine Teaches Lessons
Associated Press, 20 October 2004

Companies Find Flu Vaccine More Trouble than It's Worth
Washington Post, 17 October 2004

The Press Wrestles with the Politics of Flu
Columbia Journalism Review, 20 October 2004

Nat'l Vaccine Supply Report - Liability Issues
Nat'l Vaccine Advisory Council, January 2000

Major Cases Litigated by John Edwards
Findlaw Legal News and Commentary

Rumor Blames Edwards
Raleigh News & Observer, 29 October 2004

Last updated: 10/29/04