The New York Times reports that once again patients have been injured by FDA-approved products. Unfortunately, these patients, like thousands of others harmed by other FDA-approved devices, will likely have no legal recourse for their injuries as a result of the U.S. Supreme Court’s February 2008 Riegel v. Medtronic, Inc. decision.
In Riegel, the Court immunized medical device manufacturers from lawsuits by patients who are injured by defective premarket approval medical devices. The Court reached this result by deciding such claims are barred by a preemption clause included in the Medical Device Amendments of 1976, and the hope that approval by the FDA will adequately protect patients from unsafe medical devices. Unfortunately, as the New York Times reminds us, patients continue to suffer serious injuries from defective FDA-approved devices.
The Riegel decision bypasses congressional intent and the past thirty years of the U.S. Food and Drug Administration (FDA) playing a complementary role with tort liability in protecting consumers. Tell Congress to enact the Medical Device Safety Act in order to fix this glaring unjustice.