Dalkon Shield - Aftermath

Aftermath

More than 300,000 lawsuits were filed against the A.H. Robins Company – the largest tort liability case since asbestos, and the federal judge, Miles W. Lord, made history with the judgments, personal liabilities and public rebukes of the company heads. The cost of litigation and settlements (estimated at billions of dollars) led the company to file for Chapter 11 bankruptcy protection in 1985. As a result, the stock value of the company quadrupled, and Robins was able to sell the company for a hefty profit to American Home Products, (now Wyeth).

American Home Products took over responsibility for the liability, and contested victims' claims for the next 15 years. It is estimated that the interest on Dalkon Shield profits they collected during the case earned more than payments to the victims, 15 years later. The average claimant represented by a lawyer got $21,000. The largest single payment was more than $2.2 million, to the family of a severely deformed girl who was conceived while her mother was using a Dalkon Shield.

In 1976, the Medical Device Amendments to the Food, Drug, and Cosmetic Act mandated the U. S. Food and Drug Administration for the first time began to require testing and approval of "medical devices", including IUDs.

The Dalkon Shield became infamous for its serious design flaw: a porous, multifilament string up which bacteria could travel into the uterus of users, leading to sepsis, injury, miscarriage, and death. Modern Intrauterine devices (IUDs) use monofilament strings which do not pose this grave risk to users.