US confirms federal authority for safety of medical devicesBMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39503.345694.DB (Published 28 February 2008) Cite this as: BMJ 2008;336:470
- Fred Charatan
In a landmark decision, the US Supreme Court voted by eight to one last month to bar a lawsuit in a state court brought by the widow of a man injured by a cardiac catheter that had been approved for sale by the Food and Drug Administration.
When Congress enacted the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act, it gave the responsibility for overseeing the safety of medical devices to the FDA and over-ruled state oversight laws.
The dispute the Supreme Court had to settle was whether an injured patient could challenge …