The experts had just pronounced the Salk anti-polio vaccine both safe and effective. Three years ago, University of California Psychologist Robert M. Gottsdanker was delighted when he succeeded in getting one of the first shots for daughter Anne Elizabeth,” 5. Equally happy was Engineer Charles Phipps of Monrovia (near Los Angeles), who got a shot for his son James Randall, 15 months.
Within a fortnight, the joy gave way to anguish. The Gottsdanker and Phipps youngsters, like 77 others inoculated with vaccine made by Berkeley’s Cutter Laboratories, came down with polio.* Live virus was found in six (of 17) Cutter vaccine batches. The U.S. Public Health Service reached the “presumption” that the cause of the disease in people getting shots from the six batches was the vaccine itself, promptly tightened up its previously hit-or-miss testing methods to make sure that no more live virus got through.
Nothing Left? Last week, little Anne Gottsdanker was in Alameda County Superior Court; she was paralyzed in both legs, had a heavy brace on one. Randy Phipps dangled a severely disabled left arm. For 27 days, a jury of eight women and four men under Judge Thomas J. Ledwich had heard reams of technical testimony to help them decide: Was the children’s polio caused by the vaccine? Was there live virus in the vaccine? If so, was Cutter negligent in letting it get through? Was there, with every ampoule of vaccine, an “implied warranty” that the preparation was safe? On their answers hung suits for $300,000 by the Gottsdankers, $65,000 by the Phippses.
For the jury, the first two answers were easy: yes on both counts. The issue of negligence developed into a long-distance battle between two giants of medical science. From Pittsburgh came a massive, 142-page deposition by Vaccinventor Jonas E. Salk, called by the plaintiffs’ resourceful, aggressive Attorney Melvin (“King of Torts”) Belli (pronounced bell-eye). Though Dr. Salk expressed no overt criticism of Cutter, if the jury believed him it had to conclude that something went wrong at Cutter. For Salk stuck doggedly to his view that the killing of polio virus with formaldehyde solution to make a safe vaccine is a “first-order reaction” and that its progress and its end point (when there should be not a single particle of live virus left) can be predicted and plotted with a straight-line graph on logarithmic paper.
The trouble, he conceded, is that only the amount of virus killed during the first few days can be measured; after that, there is so little left alive that it may not be detectable. But, he insisted, it goes on getting killed at the same proportionate rate. Practical results in his own laboratory have proved his theory, said Dr. Salk; he can produce safe vaccine with no live virus every time. So could other manufacturers at the time of the Cutter incident. He doubted that some of the tougher testing requirements later imposed by P.H.S. were necessary.
No Straight Line? The University of California’s famed Virologist Wendell M. Stanley took sharpest issue with Salk. A Nobel Prizewinner himself for original work in crystallizing viruses. Stanley flatly denied Salk’s theory that formaldehyde kills polio virus particles in a neat, straight-line fashion. “I have seen many times where the curve does not follow that theory,” he said—and not only in his own laboratory, but also in big vaccine factories. As for the testing methods before the “incident,” Dr. Stanley declared: “In the light of subsequent knowledge, they were grossly inadequate.” The implication: given the testing methods then in force plus a basically unpredictable method of vaccine-making, things could go wrong without any negligence.
The jurors took two days to decide, despite their admiration for Dr. Salk took Dr. Stanley’s word that the testing methods were more to blame than Cutter. They voted, 10 to 2, that Cutter had not been guilty of negligence “under the conditions prevailing at the time.” Even though they protested that the law of warranty as spelled out for them by the judge was “extremely harsh,” they voted 11 to 1(a majority of nine would have been enough under California law) to award damages on this score: $131,500 to the Gottsdankers and $15,800 to the Phippses. As Cutter’s attorneys got set to appeal, 44 others claiming to be victims of Cutter vaccine prepared to press suits totaling about $10,000,000.
*As did 125 close contacts (mostly kin) of those who got the vaccine. There were eleven deaths. Vaccine from Wyeth Laboratories was suspected of causing several cases of polio but no live virus was found in it.
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