Burningham v. Wright Medical Technology, Inc.

Dale Burningham (plaintiff) had surgery to install artificial hip implants in both hips. Unfortunately, the device implanted in Dale’s left hip failed, along with the parts implanted in both hips. Dale and his wife, Lana Burningham (plaintiff), brought suit in federal district court against manufacturers Wright Medical Technology, Inc., and Wright Medical Group, Inc. (collectively, Wright Medical) (defendants). The Burninghams’ claims included strict liability based on the defective design of the hip-implant products. Wright Medical moved for dismissal, asserting that the unavoidably-unsafe exception applied to automatically immunize its devices from strict-liability claims based on defective product design. Utah law imposed liability on the sellers of defective products. An exception existed for an unavoidably unsafe product, which referred to a product that could not be made completely safe even using best efforts and for which a product’s benefit justified the risk of using it. Utah law had extended the unavoidably-unsafe exception to apply automatically to all prescription drugs that had Food and Drug Administration (FDA) approval, which were subject to extensive FDA regulation. Regarding medical devices, the United States Supreme Court had determined that the federal Medical Device Amendments Act preempted tort claims under state law for devices that had been approved through the FDA’s stringent premarket approval process designed to assess safety and effectiveness. New Class III devices, which included those with the greatest risk of harm to consumers, were required to undergo this approval process. However, the FDA cleared some Class III devices, including Wright Medical’s implants, by permitting them to enter the market through its review or 510(k) process, which did not assess safety. Through the 510(k) process, products entered the market simply by a manufacturer’s showing that its device was similar to an existing device already on the market. The federal district court certified questions to the Utah Supreme Court regarding the applicability of the unavoidably-safe doctrine to devices cleared by the FDA in this manner.