Although medical devices can offer profound life-enhancing and life-extending benefits, they may also come with significant risks--especially newly designed implantable devices, which may have unanticipated interactions within the sensitive ecosystem of the human body. As a result, we've observed that product liability lawsuits and settlements are particularly frequent in the medical device sector, and many leading medical device companies have recorded significant legal expenses and reserves for these claims (see tables 1 and 3). In our view, product liability is of greater concern for medical device companies than for those in other sectors. This is true even relative to companies in the adjacent pharmaceuticals sector, for several reasons: The extensive series of clinical trials required for drug approval are more
