Frank Griffin, M.D., J.D.
Implantable medical devices have a considerable effect on the health and finances of Americans. Around seven million people a year undergo some type of implantation procedure in what has become nearly a $200 billion per year industry. In his Article, The Trouble with the Curve: Manufacturer and Surgeon Liability for “Learning Curves” Associated with Unreliably-Screened Implantable Medical Devices, Frank Griffin an orthopedic surgeon turned lawyer explores the legal and surgical risks associated with introducing new medical devices into the market. More specifically, Griffin addresses the “learning curve” for surgeons in implanting the new device and how this learning curve increases the risk of complications for a short time after the device is initially introduced. Griffin takes up the issue of whether the presence of a learning curve is evidence of defective design under a risk-utility balancing approach as well as the implications for a surgeon implanting newly designed devices under the Learned Intermediary Doctrine.