Bendectin: review of the medical literature of a comprehensively studied human nonteratogen and the most prevalent tortogen-litigen.

OBJECTIVE

to review the extensive literature pertaining to the reproductive and teratogenic effects of Bendectin and the opinions of the scientific experts for the defense and plaintiff. These data were evaluated with regard to the reproductive risks of Bendectin providing a scientific framework for evaluating the views of the experts in the Bendectin litigation.

DESIGN

the Bendectin literature was primarily obtained from articles cited in Research Alert of the Institute for Science Information. Other articles were obtained from Medline, review articles, and colleagues. An attempt was made to be all-inclusive, citing and reviewing all articles related to each subject being discussed. The literature includes epidemiologic studies, animal studies, in vitro studies, and basic science articles related to the principles of teratology and reproductive toxicology. Review articles, meta analyses, editorials, commentaries, articles in the press, and case reports were also included.

METHODOLOGY

the methodology utilized for the evaluation of Bendectin teratogenicity was presented. It consists of a five-part analysis of epidemiologic studies, secular trend analysis, animal studies, dose-response relationships, and biologic plausibility.

CONCLUSION

the five-part analysis of Bendectin reproductive effects indicates that therapeutic use of Bendectin has no measurable teratogenic effects. Presentations by many of the plantiff's experts failed to meet the scientific standards that should be expected of knowledgeable scientists and contributed to the persistence of Bendectin litigation.