Issues - Plaintiff sued Merrell Dow Pharmaceuticals claiming that Bendectin, an antiemetic, frequently prescribed prior to 1983 for the treatment of nausea and vomiting during pregnancy, and developed and manufactured by Merrell Dow Pharmaceuticals, caused specific birth defects in the children born to mothers treated with Bendectin.
Role - Expert Witness for defendant - Merrell Dow Pharmaceuticals.
Facts of the Case - Bendectin was developed in the mid-1950s by Merrell Dow Pharmaceuticals. It was indicated specifically for nausea and vomiting during pregnancy. The product was approved by the FDA in 1956 and became the leading treatment for nausea and vomiting of pregnancy world-wide for nearly three decades, being used by more than 33 million pregnant women. Starting in the late 1970's allegations regarding possible teratogenicity of Bendectin began to appear. A series of lawsuits involving the safety of Bendectin during pregnancy followed throughout the 1980s. Despite the conclusion of a FDA panel that there were no association between Bendectin and birth defects, and despite the fact that no known association between the use of Bendectin and birth defects was established in any of the legal cases, Dow Pharmaceuticals ceased production of Bendectin worldwide in 1983, as their soaring legal and liability insurance costs eclipsed sales. This deprived women in the US of the only FDA approved safe and effective pharmacological option for their nausea and vomiting during pregnancy. The drug remained approved by the FDA and continues to be safely used in Canada. By the late 1980's 750 separate cases with 1,100 claimants were consolidated into one action (MDL-486) with Merrell Dow as the defendant in the Federal Court in Cincinnati, Ohio. The jury ruled in the company's favor, and the verdict was upheld on two appeals. Despite of the lack of scientific evidence showing that Bendectin could be teratogenic, evidence that has been substantiated and bolstered by recent meta-analyses of over 200,000 women, allegations and lawsuits continue.
My Analysis - Evaluated all scientific data pertaining to the alleged reproductive and teratogenic risks of Bendectin. Reviewed all scientific literature including animal studies, human epidemiological studies and meta-analyses, in vitro studies and relevant basic science articles related to the principles of teratology and reproductive toxicology. This provided the scientific basis for evaluation of the opinions of the scientific experts for the defense and plaintiff. Analysis of all data allowed conclusion that therapeutic administration of Bendectin had no measurable teratogenic effects.
Conclusion - Collectively, all scientific studies show no difference in the risk of birth defects among those infants whose mothers had taken Bendectin during the first trimester of pregnancy and those infants whose mothers had not. Therapeutic use of Bendectin has no measurable teratogenic effects. Ruling for defendant Merrill Dow.
Robert M. Greene, PhD, received his degree in Anatomy / Developmental Biology from the University of Virginia and obtained postdoctoral training at the National Institutes of Health. As a professor at Jefferson Medical College in Philadelphia, he conducted NIH funded research into the Genetic and Biochemical Causes of Various Birth Defects, including cleft lip, cleft palate, and neural tube defects such as spina bifida.
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