<P> By 1974, approximately 2.5 million women had received the Dalkon intrauterine device . In June of that year, the Medical Director of A.H. Robins published a letter to the editor of the British Medical Journal stating that the company was aware of an "apparent increase in the number of cases of septic abortions" including 4 fatalities, but stating that "there is no evidence of a direct cause - and - effect relationship between wearing of the Dalkon Shield and the occurrence of septicemia". The letter recommended precautions including pregnancy tests for women who missed their period and immediate removal of the device in women who were found to be pregnant . In October 1974, a series of four case reports of septic pregnancies was published in the journal Obstretics and Gynecology ". In 1975, the CDC published a study associating the Dalkon Shield with a higher risk of spontaneous abortion - related death compared to other IUDs . </P> <P> As many as 200,000 women made claims against the A.H. Robins company, mostly related to claims associated with pelvic inflammatory disease and loss of fertility . The company eventually filed for bankruptcy . The company's representatives argued that pelvic infections have a wide variety of causes, and that the Dalkon Shield was no more dangerous than other forms of birth control . Lawyers for the plaintiffs argued that the women they represented would be healthy and fertile today if not for the device . Scientists from the CDC stated that both arguments have merit . </P> <P> More than 300,000 lawsuits were filed against the A.H. Robins Company--the largest tort liability case since asbestos . The federal judge, Miles W. Lord, attracted public commentary for his 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, Robins sold the company to American Home Products (now Wyeth). </P> <P> 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, to require testing and approval of "medical devices", including IUDs . </P>

Injuries caused by the dalkon shield product led to the enactment of which law