The spectacle of the FDA flaying breast implant manufactures and the President castigating drug companies has sent a cold chill through the drug and device industry. The attack by the FDA has been especially disturbing because it encourages the filing of products liability lawsuits. This leaves device manufacturers in the unenviable position of having to comply with onerous FDA regulations, then finding that this compliance provides no defense to a products liability lawsuit. In this article we briefly review the basis of products liability lawsuits and discuss a recent trend in the law that can protect medical device manufacturers from these lawsuits.
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