A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.
AMA J Ethics. 2021;23(9):E712-720. doi:
10.1001/amajethics.2021.712.
Timothy K. Mackey, MAS and Bryan A. Liang, MD, JD, PhD
Studies show that clinical practice guidelines, used by an accused physician or by patients alleging a breach of standard care, have an impact on case outcomes.