Volume 65, Issue 1, 283-309
Medical device preemption is highly controversial because it provides medical device companies with immunity from state tort claims. Congress provided medical device companies with preemption in 1976 because it was concerned that medical device companies were being overwhelmed by the costs of litigation. Congress feared that this was destroying the incentive for medical device companies to develop risky but innovative life-saving devices.Today, the dark side of medical device preemption has come to light. Medical device preemption fails to require medical device companies to account for harms that their products create for society. Medical device companies have been able to externalize the harms caused by their defective products. Many patients harmed by medical devices have been denied the opportunity to sue for redress. Further, medical device companies have been shielded from picking up the costs of their defective products. As a result, American taxpayers have been unfairly forced to pick up the tab.This Note argues that the United States government should force medical device companies to internalize some of the harms created by their products by creating a National Medical Device Injury Compensation Program modeled after the National Vaccine Injury Compensation Program. The government should also create a National Medical Device Insurance Fund. These two programs would force medical device companies to internalize some of the costs of their defective medical devices and provide a remedy for patients harmed by medical devices. Further, these solutions would preserve the life-saving benefits of medical device innovation.