Test Case
THE CUTTER INCIDENT: How America’s First Polio Vaccine Led to the Growing Vaccine Crisis. By Paul A. Offit. Yale Univ Press. 238 pp. $27.50
the polio vaccine is one of medicine’s great success stories, but its development makes for a dirty, dangerous, and far from edifying tale. Mistakes were made, as the political phrase goes, and some of those mistakes cost lives before other lives were saved. In the first half of his book, Paul Offit, a physician, achieves an almost thrillerlike intensity with a fast-paced account of the many tribulations and errors that preceded the Salk vaccine’s momentous triumph. But in attempting to trace so much of the modern antagonism between our legal and medical systems back to a single source—the Cutter incident of the title—Offit allows outrage to overwhelm reason.
Early efforts, in the 1930s, to create a polio vaccine were, by modern standards, staggeringly irresponsible. Physicians tried to kill or inactivate infectious matter in ways that bordered on quackery, then without further ado injected the products into hapless children, many of whom died or suffered enormously. It wasn’t until the 1950s that Jonas Salk devised a method to render the virus incapable of causing disease while leaving it sufficiently intact to stimulate the body’s immune system to generate a potent response against the live virus. After a rushed but successful government-backed test in 1954 on almost two million children, federal officials decided—under enormous public and political pressure—to swing into full-scale production of the vaccine.
But Salk’s instructions for making vaccine were more recipe than engineering blueprint, and the several pharmaceutical companies engaged to mass-produce the vaccine had trouble scaling up the process. Remnants of live virus contaminated many batches, and in 1955, one company, Cutter Laboratories of Berkeley, California, sent out quantities of vaccine that infected hundreds of thousands of children, severely injuring almost 200 and killing at least 10.
Then came the inevitable lawsuit, captained by Melvin Belli, who fashioned a high-profile career making legal innovations in everything from tort cases to Hollywood divorces. The unwelcome novelty here, Offit complains, is that although the Cutter jury concluded that the laboratory had acted in good faith and done nothing culpably wrong, the judge’s instructions obliged them to impose damages on the company. Thus was born the legal notion of no-fault liability.
The result, according to Offit, is today’s punitive legalistic culture, in which the minutest dangers, real or sometimes imaginary, blossom into multimillion-dollar payouts, and the quest to eliminate risk, far from making medicine safer, stifles innovation and keeps promising treatments off the market. But this grandiose contention doesn’t hang together: Offit’s own review of legal history shows that the Cutter decision fits into an evolution of liability law that started centuries ago and continues to this day.
Offit also inveighs against bad science in the courtroom, citing among several examples the case of an effective vaccine for Lyme disease that was withdrawn from the market in 2002 after the manufacturer came under legal attack on extremely dubious scientific grounds. Lawyers browbeat juries into blocking life-saving medicines! It’s a good punch line, with enough truth in it to warrant intelligent scrutiny. But Offit, having praised the Cutter jurors for evaluating the scientific evidence carefully, now wants somehow to blame them for the increasingly irresponsible decisions of their successors.
Today’s litigious society is surely a remarkable phenomenon, but the Cutter incident is at most a small element in a plot vaster than Offit’s book can handle. As it happens, the Journal of the American Medical Association published a study on October 12, 2005, concluding that among the many factors making flu vaccine production commercially unattractive, legal liability issues represent only a minor nuisance. It may well be true, as Offit asserts, that the pharmaceutical industry is reluctant to spend money looking for new vaccines—but it apparently has limitless dollars available to create and market pills that help middle-aged men get firmer erections. Something’s out of whack here, and you can’t pin all the blame on nefarious lawyers.
—David Lindley