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What Went Wrong And When? A Framework For Assessing Medical Device Product Liability and Patient Safety. Written By Brian Moher, Senior Associate Establishing liability is always critically important in personal injury law. In many cases, determining who is responsible for a person’s injuries is straightforward. But when a medical device is involved, some additional sleuthing may be required. If a person is injured by a medical device, the list of potentially negligent parties can be lengthy. The medical device manufacturer, regulatory body, distributor, purchaser, healthcare practitioners, healthcare facilities and staff, or patient could all have a role to play in what went wrong. Was the product not only safe to use, but safe for the individual patient to use? Was there a design flaw? An error in the manufacturing process? Damage during distribution? Improper use? Lack of training? Poor maintenance and storage? Were there factors unique to the patient that made this device unsafe for them specifically? Did more than one thing go wrong between a medical device’s design and its end use? These are questions a plaintiff and their lawyer will want to answer as they prepare to launch a civil action. In this blog post, I’d like to outline a simple, easily adaptable three-step process for assessing liability in medical device cases.