Companies, Courts, and the Cutter Case

On April 12, 1955, five pharmaceutical companies released several million doses of Jonas Salk's formaldehyde-inactivated polio vaccine. Two weeks later, an outbreak of paralysis occurred in California and Idaho. Children inoculated with Salk's vaccine were getting polio and spreading the disease to others.

Paul A. Offit, MD

Within months of the outbreak, the Communicable Diseases Center discovered that Cutter Laboratories of Berkeley, California had failed to completely inactivate the polio virus in its vaccine. As a consequence, 70,000 people developed mild polio, 200 were permanently and severely paralyzed, and 10 were killed. It was one of the worst pharmaceutical disasters in American history.

Soon after the Cutter tragedy, Jonas Salk realized that cell debris, present in the vaccine as a consequence of inadequate filtration, prevented exposure of poliovirus particles to formaldehyde. As a consequence, Cutter's vaccine contained live, fully virulent poliovirus. Salk's observations stimulated a change in federal requirements for vaccine manufacture, and the incidence of polio declined dramatically.

Two years after the tragedy, Cutter Laboratories was taken to court. Lawyers for Cutter showed the jury that all five companies manufacturing the vaccine had had difficulties completely inactivating poliovirus. Realizing that large-scale manufacture of polio vaccine was still an evolving process, the jury found that Cutter Laboratories was not negligent. But the judge instructed the jury to find Cutter liable if they believed that its polio vaccine had caused harm. For pharmaceutical companies, liability without fault was born.

Because proof of negligence was no longer required, decisions about liability now rested solely on a judge's or a jury's perception of cause and effect. Unfortunately, judges and jurors have sometimes made decisions with little basis in scientific fact. Some decisions were based on erroneous assumptions such as:

• Silicone-filled breast implants cause connective-tissue diseases.

• Spermicidal jellies cause birth defects.

• "Bendectin," a drug for morning sickness, caused birth defects.

Although the Cutter incident brought federal regulation of vaccines out of its infancy—making for better, safer products—the final, ironic legacy of the tragedy may lie in a court ruling that caused far more harm than good.

So, what's the solution? Perhaps the best system to protect pharmaceutical companies from the harm of frivolous litigation and massive awards can be found in the National Childhood Vaccine Injury Act (NCVIA). Passed by Congress in 1986, the NCVIA protects vaccine manufacture in the United States by directing all claims to a panel of scientists, epidemiologists, and clinicians that review existing data and decide whether a claim has merit. If it does, plaintiffs are compensated quickly, generously, and fairly. The program is funded by a federal excise tax on the cost of every dose of vaccine. "Vaccine court" saved vaccine manufacture in the United States.

This system could be applied to drugs. As in the case of vaccines, the price of every dose of a drug would include a small federal excise tax that would be used to fund the compensation program. The determination of whether a drug actually causes harm would be made by a panel of experts that could rely on a large, interlocking series of HMO databases to determine quickly whether an adverse event is causal or coincidental (similar to the Vaccine Safety DataLink used for vaccines). By protecting pharmaceutical companies against massive awards not based on science that threaten their viability, "drug court" could lower the price of drugs and make for better, more affordable health care.

Paul A. Offit, MD is the chief of infectious diseases at the Children's Hospital of Philadelphia, 34th St. and Civic Center Blvd., Abramson Bldg, 12th floor, Rm #1202 C, Philadelphia, PA 19104-4399, tel. 215.590. 2020, offit@email.chop.edu