When risk managers first heard that there wouldn’t be enough flu vaccine from the two manufacturers still providing it, many probably reacted with the same thought: That’s what you get when money-hungry trial lawyers run health care companies out of business. But is that really the cause of the flu vaccine shortage? The two opposing sides in the tort reform debate disagree about the answer, but it seems clear that more than that one cause caused the vaccine shortage.
The American Tort Reform Association (ATRA) in Washington, DC, says fear of liability most certainly was a contributing factor. The group is urging Congress to act on what it calls "the excessive liability exposure that has led to the recent flu vaccine crisis in the United States."
ATRA general counsel Victor Schwartz, JD, says the shortage was inevitable when the United States depended on only two vaccine manufacturers. And why were there only two? Because American companies were afraid to take on the trial lawyers who would sue the manufacturer for any problems, real or perceived, after someone receives the vaccine, he says. "We’ve been cautioning policy-makers and the American public for more than 10 years not to be too dependent of foreign vaccine manufacturers, and now we have a real crisis," Schwartz says. "Now that one foreign manufacturer has withdrawn its flu vaccine from the market, we must make every effort to assure that there is a liability climate so that vaccines can again be manufactured here in the United States."
Schwartz notes that at one time, there were more than 12 U.S.-based vaccine manufacturers.
American manufacturers are very reluctant to produce vaccines because they generally are given to healthy people, Schwartz explains. ATRA president Sherman Joyce says that if a person who has received a vaccine suffers any type of disability, there is a plaintiffs’ lawyer waiting in the wings to sue a manufacturer. "Courts that admit junk science evidence have helped create this crisis," Joyce says. "A vaccine manufacturer can be held liable for millions of dollars, even though its product had nothing to do with the plaintiff’s actual injury."
Schwartz says the problem could be solved with federal legislation that would assure persons who are actually injured by vaccines receive prompt and fair payment, similar to the 1986 National Childhood Vaccine Injury Act, which does not apply to flu vaccine. The childhood vaccine program limits the liability of manufacturers enough that companies are willing to stay in the business, he says.
Lawyers say it’s not their fault
But, not surprisingly, the trial lawyers have a different view. The Association of Trial Lawyers in America, based in Washington, DC, argues that its members are not the root cause of the shortage and that protecting manufacturers from liability is not the answer.
ATLA president Todd A. Joyce, JD, a trial attorney in Chicago, notes that even with liability protections, there are still shortages of childhood vaccines. Since 2000, there have been shortages of eight of the 11 vaccine-preventable childhood infectious diseases plus adult vaccine shortages, the ATLA reports.
Joyce argues that flu vaccine shortages are unrelated to liability. Instead, he says, there are so few flu manufacturers because it is a risky business. Flu vaccine manufacturing is very risky for a number of reasons, most notably because demand for it varies from year to year. Plus, any product that is not sold cannot be saved or stockpiled because a new vaccine must be developed each year to deal with changing strains of the virus.
Few lawsuits filed
Quality control and safety regulations also are a big deterrent, he says. In the late 1990s, the FDA tightened its inspections of factories making biologic products after contamination of blood products by the AIDS virus and other incidents led to criticism of the agency’s inspections. While manufacturing costs have increased, the prices for the vaccines have remained the same.
Joyce reports that there have been very few lawsuits against flu vaccine manufacturers. An ATLA search of lawsuits from 1980 to the present found only 46 reported cases based on flu vaccine injuries, he says. Of the 46 cases, 39 involved the swine flu vaccine, and only seven involved the standard flu vaccine. In five of the seven standard flu cases, the defendant prevailed, while the other two cases are unreported.
"Given the millions of vaccine doses dispensed every year, this is hardly a liability crisis," he says.