Stephen J.LurieMD, PhD, Senior Editor
In Reply: Mr Noah and Dr Weintraub criticize us for omitting an analysis of the variable decisions of state and federal courts. We believe that the broad confusion in the federal courts aptly illustrates the point and justifies a focus on those critically important decision-making bodies. The criticism by Noah of our depiction of the FDA is also unjustified. The low threshold for action, we averred, was directed at warnings of adverse events, not determinations regarding approved uses or labeling decisions.
Kassirer JP, Cecil JS. Standards for Medical Expert Testimony. JAMA. 2002;288(23):2972. doi:10.1001/jama.288.23.2972-JLT1218-2-4