The Magazine

La Grippe of the Trial Lawyers

From the October 25, 2004 issue: Guess who's to blame for the flu vaccine fiasco.

Oct 25, 2004, Vol. 10, No. 07 • By WILLIAM TUCKER
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"It was a turning point," says Dr. Offit, whose book The Cutter Incident will be published next year. "Because of the Cutter decision, vaccines became one of the first medical products to be eliminated by lawsuits."

That this would be the outcome wasn't immediately clear. Soon after the trial, the Yale Law Journal published an article arguing that insurance against adverse reactions was the solution. The public wouldn't buy policies because it would be too complicated and expensive, but vaccine makers could. Insurance would cover the cost of bad outcomes and the manufacturers would pass these costs on to their customers. Those few who were harmed by a vaccine would be covered by those who benefited. Everything would work out. Unfortunately, this thesis failed to anticipate how high damage awards would go.

WHEN AN UNUSUAL EPIDEMIC occurred at Fort Dix, N.J., in 1976, for example, the federal government decided to vaccinate the whole country against the new "swine flu." To the astonishment of Congress, the insurance companies refused to participate. Senator Ted Kennedy charged "cupidity" and "lack of social obligation." The Congressional Budget Office predicted that with 45 million Americans inoculated, there would be 4,500 injury claims and 90 damage awards, totaling $2 million. Congress decided to provide the insurance.

As Peter Huber recounts in his book Liability, the CBO's first estimate proved uncannily accurate. A total of 4,169 damage claims were filed. However, not 90 but more than 700 suits were successful and the total bill to Congress came to over $100 million, 50 times what the CBO had predicted. The insurance companies knew their business well.

Adding to the problem are the predictable panics about vaccines that spread among parents and are abetted by trial lawyers. In 1974, a British researcher published a paper claiming that the vaccine for pertussis (whooping cough) had caused seizures in 36 children, leading to 22 cases of epilepsy or mental retardation. Subsequent studies proved the claim to be false, but in the meantime Japan canceled inoculations, resulting in 113 preventable whooping cough deaths. In the United States, 800 pertussis vaccine lawsuits asking $21 million in damages were filed over the next decade. The cost of a vaccination went from 21 cents to $11.

Every American drug company dropped pertussis vaccine except Lederle Laboratories. In 1980, Lederle lost a liability suit for the paralysis of a three-month-old infant--even though there was almost no evidence implicating the vaccine. Lederle's damages were $1.1 million, more than half its gross revenues from sale of the vaccine for that entire year.

In recent years, the most prevalent anti-vaccine rumor has held that Thimerosal, a mercury-containing preservative used in vaccines from the 1930s until just recently, is behind an "epidemic of autism." Once again, scientific studies have disproved the allegation, but hundreds of parents are filing suit, and trial lawyers continue to troll for clients.

Congress tried to stave off liability problems with the National Childhood Vaccine Injury Act in 1986. The program functions almost as an ideal "medical court," with panels of scientists, virologists, and statisticians reviewing each complaint and rewarding those that seem legitimate. Unfortunately, the program allows plaintiffs to opt out of the system. Trial lawyers continually bypass it and elect to go to trial--particularly for cases where the review looks unpromising. With Thimerosal, lawyers have argued that the law does not apply because mercury was an additive, not the actual vaccine. The result is jackpot awards and very little protection for the vaccine companies. In 1998, the FDA approved a vaccine for Lyme disease, which strikes 15,000 people a year. GlaxoSmithKline manufactured it for three years but quit when rumors began circulating that the vaccine caused arthritis.

All this has made the flu an epidemic waiting to happen. Each year flu viruses circle the globe, moving into Asia in the spring and summer and back to North America in the winter. Surface proteins change along the way so that the previous year's vaccine doesn't work against the following year's variation.

Each year in February, the Centers for Disease Control meets with the vaccine-makers--all two of them--and decides which strain of the virus to anticipate for next year. Then they both make the same vaccine. Last year the committee bet on the Panama strain, but a rogue "Fujian" strain suddenly emerged as a surprise invader. A mini-epidemic resulted and 93 children died, only two of them properly vaccinated.