Makers of Drug Bendectin Win Appeals Round : Law: U.S. Court dismisses a decade-old case in which families claimed morning sickness medicine caused birth defects. Plaintiffs’ scientific experts failed to show link, judges rule.

A federal appeals court in San Francisco ruled Wednesday that controversial scientific studies about a drug prescribed to pregnant women for morning sickness are not admissible and dismissed a case in which two families contend that their children’s birth defects were caused by the drug Bendectin.

The U.S. 9th Circuit Court of Appeals upheld a San Diego trial judge’s ruling granting a summary judgment to Merrell Dow Pharmaceuticals Inc. in a closely watched case that has been in litigation for more than a decade and became one of the cornerstones in the controversy over so-called junk science in the courtroom.

Although the U.S. Food and Drug Administration never ruled Bendectin unsafe, Merrell Dow, based in Kansas City, Mo., stopped manufacturing the drug in 1983, citing the high costs of litigation stemming from lawsuits around the country.

Bendectin was prescribed to 17.5 million women between 1957 and 1982.

In this and other cases, plaintiffs asserted that children were born with defective limbs because the mother had taken Bendectin. In the San Diego case, one of the children was born without a hand and the other was born with an abnormally short arm.

Some juries have ruled in favor of plaintiffs, but most of those verdicts have been overturned on appeal, according to Peter W. Huber, author of “Galileo’s Revenge: Junk Science in the Courtroom,” a book cited twice in Wednesday’s decision.

Richard M. Johnson, a Merrell Dow spokesman, said more than 2,000 suits had been filed, including 1,100 in a class action that was dismissed by a Cincinnati judge in 1989. He said that 25 are still pending in this country and 21 are pending abroad. Johnson said that several hundred suits had been settled “for very small amounts.” He said juries had ruled for the company in 36 cases, six of which are still on appeal by plaintiffs.

According to Wednesday’s 3-0 decision, no published epidemiological study concluded that Bendectin increases the incidence of birth defects. In the ruling, Appellate Judge Alex Kozinski of Pasadena issued a scathing attack on the plaintiffs’ experts for failing to issue formal findings of their views and to allow review by their peers in the scientific community.

“Bendectin litigation has been pending in the courts for over a decade, yet the only review the plaintiffs’ experts have received has been by judges and juries,” Kozinski wrote.

“Despite the many years the controversy has been brewing, no one in the scientific community--except defendant’s experts--has deemed these studies worthy of verification, refutation or even comment. It’s as if there were a tacit understanding within the scientific community that what’s going on here is not science at all, but litigation.”

The decision was hailed by Harvard University law professor Charles Fried, who argued the case on appeal for Merrell Dow.

“Victory is sweet; it was a long time coming,” Fried said. “This is quintessential ‘junk science,’ people who have never put their views forward for peer review,” Fried said. He said the fact that the case has dragged on so long and that there is still the possibility of further appeal “is an embarrassment to the legal system.”

In 1993, in an earlier phase of this case, the U.S. Supreme Court issued a landmark ruling that federal judges should play an active role in ensuring that “any or all scientific testimony or evidence admitted is not only relevant, but reliable.” The court sent the case back to the 9th Circuit to apply the facts of the case to the new Supreme Court standard.

The plaintiffs relied on depositions by three groups of scientific experts to establish that Bendectin was responsible for their injuries. One group said that there is a statistical link between the ingestion of Bendectin during pregnancy and limb defects. Kozinski stressed that these experts had not conducted their own research but had only reanalyzed studies by other scientists who had reached a contrary conclusion.

Other experts said Bendectin causes limb-reduction defects in humans because it causes such defects in laboratory animals. A third group of experts said there was a link between Bendectin and birth defects because Bendectin has a chemical structure that is similar to other drugs suspected of causing birth defects.

But the 9th Circuit found that the experts were out of step with the consensus in the scientific community and that none of the experts based their testimony on pre-existing or independent research.

“None of the plaintiffs’ scientists claimed to have studied the effect of Bendectin on limb-reduction defects before being hired to testify in this or related cases,” Kozinski wrote.

Mary F. Gillick, a San Diego attorney representing the plaintiffs, said she was “disappointed but not surprised” by the ruling. Gillick said she could not comment in detail because she had not seen the opinion, but she maintained that the research of one of the plaintiffs’ experts had been submitted for peer review. Gillick said she could not say whether the plaintiffs would appeal until a team of lawyers has reviewed the decision.