Federal preemption can be a very powerful defense. For example, claims concerning Class III medical devices requiring pre-market approval are generally preempted by the Medical Device Amendments of 1976, 21 U.S.C. ยง 360c, et...more
How demanding is the causation standard in a California failure to warn claim when a learned intermediary testifies that he would have read and incorporated more stringent warnings if they had been available? Is the plaintiff...more
In June 2016, the U.S. Food and Drug Administration (FDA) issued its final rule explicitly allowing the use of approved symbols, without accompanying text, on medical device and certain biological product labeling. The FDA...more