“…These individuals mistakenly assumed that the same rigorous methods that were necessary to identify the first effect are no longer necessary, once the agent has been identified as a reproductive toxicant. There are a number of case reports of children with LRDs or other malformations who were born to mothers exposed to tetracycline during their pregnancy [Batagol, 1980;Chow and Jewesson, 1985;Carter, 1962;Carter and Wilson, 1962;Corcoran and Castles, 1977;Filippi, 1969;Morrissey et al, 1986;Medical Letter, 1985;Pomerance and Yaffe, 1973;Schwarz, 19811. Epidemiological and animal studies have not supported this allegation, yet these reports were used as a basis for birth defect litigation.…”