- The Washington Times - Sunday, June 8, 2008

ANALYSIS/OPINION:

ANALYSIS/OPINION:

Vaccines have arguably been the single most powerful contributor to longer and better life for Americans over the last century. Before vaccines, each year thousands of American children died from whooping cough, mumps, measles and diphtheria. Polio paralyzed 10,000 or more children yearly.

Do we want to put the benefits of vaccines at risk by forcing producers to run a nationwide gauntlet of lawsuits? A case heard May 20 by the Georgia Supreme Court - American Home Products v. Ferrari -raises that urgent question.

An Atlanta couple, Marcelo and Carolyn Ferrari, sued a number of vaccine manufacturers when their young son developed symptoms of autism after being vaccinated. The suit blames a mercury preservative that was used in their son’s vaccines, called thimerosal. But the question before the Supreme Court doesn’t address the validity of this controversial assertion at all. Instead, the question is more basic: Do state courts have authority to hear product liability cases of this kind, against vaccine makers?

A lower court - the Georgia Court of Appeals - answered, yes. Overruling the trial judge, the appellate panel held that federal law doesn’t block state litigation over vaccine claims. But the appellate court was wrong, and the trial court was right: The case shouldn’t have been allowed to go forward.

The federal statute that says so is the Vaccine Act, officially titled the National Childhood Vaccine Injury Compensation Act of 1986. This law establishes that vaccines are regulated exclusively at the federal level, by the Food and Drug Administration; the statute sets up a system for fast and adequate compensation for vaccine-related injuries, without resort to litigation.

The Vaccine Act is clear in prohibiting state lawsuits targeting a vaccine or ingredient that is FDA-approved - as thimerosal was at the time the Ferraris’ son was vaccinated.

If a vaccine “was properly prepared and was accompanied by proper directions and warnings,” the manufacturer can’t be sued for direct injuries allegedly caused by it.

A critical shortage of vaccines brought this law into being in the 1980s. Pharmaceutical firms faced massive lawsuit liability, forcing them to scale back or abandon production. Between 1980 and 1986, damage claims for more than $3.5 billion were filed against vaccine producers.

The companies had to reallocate revenues from vaccine research and production to the cost of insurance and lawyers. And prices for the public skyrocketed: The cost per dose of the whooping cough vaccine rose from 11 cents in 1982 to $11.40 in 1986, with $8 of this increase going toward liability insurance.

Congress’ response was the Vaccine Act, designed to ensure both that manufacturers could provide a steady supply of vaccines without a crippling liability threat, and that any harms from vaccines’ side effects would be readily compensated through a federal system of review and reimbursement.

If even one state - Georgia, for instance - opens its courts to civil suits against vaccine manufacturers, this carefully crafted federal system would be disrupted. The industry would face grave new liability dangers and the American public would find vaccines more expensive and less effective. Innovation would suffer; we would be deprived of the full benefit of medical advances.

Recognizing this danger - and that the Vaccine Act pre-empts state lawsuits - courts in other states have declined to allow civil litigation against vaccine producers. At the recent oral argument, the Ferraris’ attorney had to acknowledge this tide of cases going against his position - the “pre-emption train,” as he put it. The Georgia Supreme Court should board this train, and reverse the appeals-court decision that tried to derail it.

The health and well-being of the American public depend on availability and accessibility of effective vaccines. We cannot afford a repeat of the severe vaccine shortages of the 1980s.

Only a uniform and efficient national scheme, as under the Vaccine Act, ensures that we compensate those harmed by vaccine side-effects, without injuring the public as a whole by allowing manufacturers to be sued out of business.

Elizabeth A. Yi is a lawyer with Pacific Legal Foundation (www.pacificlegal.org), a public-interest law firm that litigates for free enterprise and limited government. In American Home Products v. Ferrari, she submitted a friend-of-the-court brief to the Georgia Supreme Court, supporting federal pre-emption of vaccine regulation.

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