The Cutter Incident: How America's First Polio Vaccine Led to the Growing Vaccine Crisis (review)

The conquest of polio is the emblematic narrative in the twentieth-century history of medicine. Here we see the trial-and-error accretion of scientific knowledge, the uneasy relationship between private-sector initiative and governmental oversight, the popular faith in the ability of medicine to free humanity from terrifying scourges, and the elevation of researchers and physicians to heroic status. The voluminous academic and popular literature on polio is a measure of this story's continuing resonance. Numerous books have traced the science, politics, and cultural meanings of polio, from its first appearance in this country in the late nineteenth century through its contemporary aftermath in the lives of disease survivors coping with post-polio syndrome. Fifteen years after the disease was eliminated from the Western Hemisphere, it continues to inspire historians: the past two years have seen at least three new works on polio and its victims, including David Oshinsky's Pulitzer Prize–winning Polio: An American Story.

One of the most compelling chapters in the story of polio is the series of events that came to be known as the "Cutter incident." In April 1955, in the midst of extraordinary public acclaim for Jonas Salk's newly licensed vaccine, dozens of people who had recently received shots came down with what appeared to be vaccine-induced cases of the disease. The CDC's recently formed Epidemic Intelligence Service swung into action and traced the cases to vaccine lots from Cutter Laboratories, whose manufacturing procedures had been insufficient to inactivate the virus. A lawsuit against Cutter subsequently found that the company had not been negligent but was nevertheless liable for damages. The case established the legal doctrine of liability without fault, according to which pharmaceutical companies could be held responsible for harm caused by their products even if they had acted in keeping with the best available methods and standards.

Although several books have dealt with the Cutter incident, the extremely consequential litigation that followed has not previously received the attention it warrants. The present book fills this gap. Paul Offit provides a detailed and cogent analysis of Gottsdanker v. Cutter, the case brought by vaccine recipients against the manufacturer, and incisive portraits of those involved, including scientists, government officials, lawyers, pharmaceutical executives, and ordinary citizens who were victims of the Cutter vaccine. These events lie at the intersection of medicine and law, and Offit guides the reader through technical aspects of both subjects with admirable clarity. He explains intricacies of the vaccine-manufacturing process, including Salk's tragically mistaken "straight-line" theory of virus inactivation, which extrapolated a linear relationship between the amount of virus that would be killed and the length of time the preparations were treated with formaldehyde. Offit also provides a lucid overview of the evolution of product-liability law and walks the reader through a concise history of damages claims.

Offit, a professor of pediatrics and immunology, is a passionate supporter of vaccines, and he makes clear that he sees the successful litigation against Cutter and the legal doctrine of liability without fault as the root of many of the difficulties plaguing today's vaccine system. The Cutter Incident is history as advocacy, and purist historians may legitimately criticize Offit's analysis as presentist. But whatever interpretive biases he has brought to his research, this is a carefully argued and persuasive book. Surprisingly, given what he views as the malign effect of litigation on vaccine production, he does not discuss the legal actions against makers of Albert Sabin's oral polio vaccine in the decade that followed the Gottsdanker verdict. This series of suits, especially two important rulings against Wyeth Laboratories, established that vaccine manufacturers had a legal duty to warn recipients of the tiny risk of paralytic polio that was an inherent property of the live attenuated virus. These cases had ramifications for vaccine liability that were...