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Public Health Law Map - Beta 5 - Medical and Public Health Law Site

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are situations where what is generally accepted is not proper behavior. [The T.J.<br />

Hooper, 60 F.2d 737 (C.C.A.2 1932).] Finally, the Frye rule proved difficult to<br />

administer, encouraging judges to allow broad latitude for the admission of<br />

questionable evidence.<br />

c) The Daubert Case<br />

The Frye rule was reviewed by the U.S. Supreme Court in the Daubert case.<br />

[Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).] This was a case<br />

brought by two children born with birth defects that they claimed were caused by<br />

an anti- nausea drug, Bendectin. The only such drug approved by the FDA (Food<br />

<strong>and</strong> Drug Administration) for pregnant women, it had been given to more than<br />

17,500,000 women before being taken off the market. Plaintiffs’ attorneys argued<br />

that thous<strong>and</strong>s of children were born with birth defects to mothers who had taken<br />

Bendectin <strong>and</strong> this proved that Bendectin caused birth defects. Although extensive<br />

studies had not shown Bendectin to have any teratogenic effects, plaintiffs had<br />

“experts” who disagreed with these studies, based on their own unpublished <strong>and</strong><br />

unreviewed work. Using these experts, plaintiffs had filed many cases against the<br />

manufacturer, Merrell Dow Pharmaceuticals.<br />

The Daubert case turned on whether Bendectin, a anti- nausea drug for pregnant<br />

women, caused non-specific birth defects. As with all cases involving non-specific<br />

birth defects, the key scientific issue is sorting the defects allegedly caused by the<br />

teratogen from the high (1-6%, depending on severity) background level of birth<br />

defects. All of the formal scientific studies had shown no correlation between<br />

Bendectin intake by a pregnant woman <strong>and</strong> birth defects in her child. The plaintiffs<br />

had an expert who was qualified by training <strong>and</strong> experience - the main st<strong>and</strong>ard<br />

pre- Daubert - but whose methods of analysis of the data were not accepted by<br />

other scientists <strong>and</strong> had not been subjected to peer review in the literature. The trial<br />

court excluded the evidence, holding that the federal rules required the judge to act<br />

as a "gatekeeper" to prevent the jury from hearing unreliable evidence or evidence<br />

whose value was outweighed by its prejudicial nature. Prejudice jury was<br />

especially important in the Daubert case because of the emotional appeal of a birth<br />

injured baby plaintiff. The judge knew that if there was any evidence to support the<br />

plaintiff's case, it would be very difficult for the jury to find against the plaintiff.<br />

This created a special duty to assure that the plaintiff's evidence was scientifically<br />

valid.<br />

Plaintiffs had not been successful in any of the Bendectin lawsuits at the time of<br />

the Daubert case, but the costs of defense were so high that Merrell Dow had taken<br />

the drug off the market. It was assumed by plaintiffs that they would eventually get<br />

a substantial settlement from Merrell Dow, either because they would finally win<br />

one of the cases, or just to end the defense costs. In the Daubert case, the trial<br />

judge determined that plaintiff’s experts were not credible because their evidence<br />

did not meet the Frye test requirements of general acceptability. Such a finding is<br />

critical to the defense because it stops the lawsuit before the costs are too high, plus<br />

160

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