In a June 28 ruling on a case involving charges that a drug formorning sickness caused limb deformities, the U.S. SupremeCourt established new rules on the use of scientific evidence incourt.

Several observers told BioWorld that the new rules shouldreduce somewhat the amount of litigation the biotechnologyindustry will face both from product liability cases and fromconsumer activists.

"This would lead litigants to think twice before they bring any'junk' science into the evidentiary arena," Mark Frankel,director of the Scientific Freedom, Responsibility, and LawProgram of the American Association for the Advancement ofScience, told BioWorld.

In Daubert v. Merrill Dow Pharmaceuticals, the plaintiff'sattorney, in his effort to prove that the drug Bendictin hadcaused limb deformities, tried to enter into evidence ananalysis that used methods that had neither been publishednor reviewed by other scientists, Frankel told BioWorld. "Therewas no basis for thinking this methodology has any validity atall."

The ruling, which sent the case back to a lower court, wouldrequire judges to rule on admissibility of scientific evidenceaccording to certain standards rather than allow juries to beswayed by the superficially sound arguments of lawyers, PaulRothstein, professor of law at Georgetown University LawSchool and scientific evidence consultant to the NationalAcademy of Sciences, told BioWorld.

The ruling would bar so-called junk science by requiringscientific evidence to conform to the scientific method. But itwould also admit scientific evidence that has not been widelyaccepted on this same basis. Modern-day Galileos, for example,would be able to present evidence from science not publishedin a peer-reviewed journal as long as their methodology issound.

The ruling "has the potential of resolving matters before theyget to juries," Frankel told BioWorld. "It may lead to a lot morepretrial settlements than we have seen in the past."

This could reduce the burden of product liability suits.

Peter Huber, author of Galileo's Revenge: Junk Science in theCourtroom and a lawyer who clerked for Supreme Court JusticeSandra Day O'Connor and nominee Ruth Ginsburg, added, "Ithink it's generally favorable for people who do good science."

As for the Jeremy Rifkins of the world, Huber told BioWorld:"The standard articulated in Daubert says that judges mustascertain both the relevance and the reliability of scientificevidence. As a general rule, the far fringe opponents of yourindustry are not using reliable methods. Their riskprognostications tend to be highly speculative."

Frankel said the decision will likely cause judges to takeadvantage of outside experts more often than they have in thepast.

-- David C. Holzman Washington Editor

(c) 1997 American Health Consultants. All rights reserved.