A.H. Robbins Co.

The A. H. Robbins Company, manufacturers of pharmaceuticals, acquired rights in June 1970 to a new contraceptive for women. The Dalkon Shield, an intrauterine device, was marketed as a safer method of contraception than the birth control pill, and stated it could be used by the vast majority of women, according to its designers. At that time the Dalkon Shield was not subject to rigorous clinical testing because it was not classified as a drug under the terms of the Federal Food, Drug, and Cosmetic Act.

A flaw in the Dalkon Shield, coupled with Robbins's disregard of cautionary medical advice, resulted in a long list of serious injuries to hundreds of thousands of its users. Twenty American women died from septic abortions caused by using the Dalkon Shield. Hundreds of women became sterile, and many required hysterectomies. In addition, countless miscarriages, infections, and reproductive disorders resulted from its use.

In June 1974, Robbins 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.

Congress responded to the Dalkon Shield fiasco by enacting the Medical Device Amendments of 1976, which authorized the FDA to review the safety and effectiveness of medical devices like the Dalkon Shield. The tobacco and pharmaceutical industries funded critics and think tanks to publicly criticize the FDA and portray it as a bureaucratic "job killer." They accused the agency of killing thousands of Americans by delaying access to innovative drugs and medical devices. They ran ghastly scare ads featuring coffins and tombstones of the agency's alleged victims.

The case also raised issues pertinent to the tobacco industry, about how much information regarding a product a corporation should be allowed to keep secret, how much harm a product must do before recall, etc.

A.H. Robbins was a member of the Coalition for a Uniform Product Liability Law circa 1988, which lobbied for legislation capping punitive damages and pain and suffering compensation from people hurt by products.

External Resources
March 1997 Henry Waxman Op Ed reflecting on the Dalkon Shield episode and its significance to efforts to weaken safety standards