摘要：It is difficult to understand how a product so intimately connected with a bodily function and presenting such a potential for serious harm was allowed on the market without pre-market clearances assuring that it had met at least minimum standards of safety. This development is especially distressing since there exists a governmental agency whose sole function is to protect the public interest in precisely this type of situation. Since the law of products liability should not deny a remedy to the unwary consumer whose reliance on the overzealous representations of the manufacturer ended in tragedy, this note will examine the conduct of the FDA and FTC in light of existing legislation and case law in an effort to ascertain whether they have adhered to the mandate of Congress, and analyze the potential liability of the IUD manufacturer and the prescribing physician in light of the present law of products liability.
关键词：FDA; medical devices; product liability; IUD; manufacturer liability; FTC
