Federal Judges v. Science

Katie Wells was born in 1981 with serious birth defects. Her parents attributed them to a contraceptive jelly and sued the maker, Ortho Pharmaceutical Judge Marvin Shoob of the U.S. District Court in Georgia ruled they had proved their case and assessed $5 million in damages against Ortho. The Court of Appeals declined to overturn the judgment and last month the Supreme Court refused to intervene. What is wrong with that? First, the facts. Scientific experts often differ and the courts generally decide, with some skill, which to believe. But with spermicides like Ortho's there is no serious difference among experts. After reviewing some 20 epidemiological studies, an expert committee advised the Food and Drug Administration in 1983 that the preponderance of available evidence "indicates no association" between spermicides and birth defects. How then could Judge Shoob have ruled otherwise? Despite the written evidence of the scientific literature, he focused on the real testimony given in his court, and says he "paid close attention to each expert's demeanor and tone." Ortho's witnesses included prominent epidemiologists but were gravely deficient in the demeanor department. One had impressive credentials, Judge Shoob conceded yet "lacked credibility." Of another, the judge said "his overall demeanor and manner indicated a degree of bias." He cited objective grounds for doubting one main witness, who had not disclosed that he consulted with Ortho before participating in the Federal review of the jelly's safety. Judge Shoob, who sat without a jury, chose instead to believe the plaintiff's main witnesses, three pharmacologists and an expert in birth defects, none of whom had any expertise in epidemiology, the science of determining the causes of disease. Typically their demeanor was—in the judge's words—"excellent." He ruled they had shown Ortho's jelly caused Katie Wells's birth defects. Science's finest achievement is finding methods to raise objective evidence above the merely anecdotal. Judge Shoob was not moved by the preponderance of scientific evidence—and neither was the Appeals Court. It espoused the fiction that there had been a battle of experts, even though no scientist would consider pharmacologists expert in a matter of epidemiology. The Court of Appeals explicitly rejected scientific standards of proof; "What matters," the court declared, "is that [Judge Shoob] found sufficient evidence of causation in a legal sense in this particular case, and that that finding is not clearly erroneous." Ortho argued in vain that the Court of Appeals should have held Judge Shoob's reasoning to a higher standard than "not clearly erroneous." The Supreme Court refused to hear the case. Thus the Federal judiciary has placed itself opposite the best judgment of the scientific community. As is noted in The New England Journal of Medicine, "The Wells v. Ortho decisions are of great concern to the medical community because they indicate that the courts will not be bound by reasonable scientific standards of proof." The practical consequences of the Ortho decision could be profound. Spermicides are used by some three million women, particularly by teenagers, who can buy them without a prescription. Profits are small. Ortho makes $3 million a year on its product and a few more such suits will drive spermicides off the market, like intrauterine devices before them. Contraceptive choice for all women will be further narrowed. In their different ways, both law and science seek after truth. That Judge Shoob and the appellate judges ignored the best scientific evidence is an intellectual embarrassment. The practical result is that many citizens may suffer. This editorial appeared in the December 27, 1986 issue of The New York Times. Copyright © 1986 by the New York Times Co. Reprinted by permission.

Federal Judges v. Science

The Scientist Staff

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