“Last week, the US Supreme Court ruled that patients injured by defective medical devices have no right to sue for damages if the devices were approved by the Food and Drug Administration. The decision would be defensible if the 1976 law on FDA oversight of devices actually called for such a sweeping immunity from liability, or if the agency’s review process for devices and drugs were uniformly thorough, science-based, and immune from commercial pressures. Neither is the case. The 1976 law contains provisions that, according to its congressional supporters, were meant to keep states from requiring their own duplicative approval procedures for new devices. It was not meant to prevent suits by victims of defective devices. In the case before the Supreme Court, the suit was brought on behalf of a man injured during an angioplasty by the bursting of a balloon catheter for a coronary artery.” (02/28/08)