A.H. Robbins Co.
In June 1970, the A. H. Robins Company, manufacturers of pharmaceuticals, acquired rights to a new contraceptive for women. The Dalkon Shield, an intrauterine device, was a safer method of pregnancy prevention than the birth control pill and could be used by the vast majority of women, according to its designers. At that time under the terms of the Federal Food, Drug, and Cosmetic Act, the Dalkon Shield was not subject to rigorous clinical testing because it was not classified as a drug.
A flaw in the Dalkon Shield coupled with Robins's disregard of cautionary medical advice resulted in a long list of serious injuries to hundreds of thousands of its users. In June 1974, Robins suspended domestic sale of the Dalkon Shield (foreign distribution continued for another ten months) but stopped short of recalling it, defending its safety and effectiveness "when properly used." Eleven years later, the company declared bankruptcy in the face of claims filed against it as a result of the defective IUD.