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Golden Gate University School of Law

Health Law and Policy

Product liability

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Reforms In Medical Device Regulation: An Examination Of The Silicone Gel Breast Implant Debacle, Rebecca Vveisman Sep 2010

Reforms In Medical Device Regulation: An Examination Of The Silicone Gel Breast Implant Debacle, Rebecca Vveisman

Golden Gate University Law Review

This article will consider the regulatory policies of the FDA in protecting the health of the nation's women, particularly its handling of silicone gel breast implants and its policing of the leading implant manufacturer, Dow Corning Corporation. While this article recognizes the various difficult problems which the FDA must address in protecting consumers from unsafe food, drugs, and medical devices, it also recognizes the need for reform. This article will describe what resulted from the tragedies of diethylstilbestrol (DES) and the Dalkon Shield. With these failures in mind, this article will examine present FDA policies, describe social forces outside of …


Sindell V. Abbott Laboratories: A New Avenue For Des Litigation, Michael H. Wells Sep 2010

Sindell V. Abbott Laboratories: A New Avenue For Des Litigation, Michael H. Wells

Golden Gate University Law Review

No abstract provided.