On May 12, 2009, the House Energy and Commerce Subcommittee on Health held a hearing on the Medical Device Safety Act of 2009. HR 1346 would overturn the February 2008 Supreme Court decision that, for the first time, denied patients the right to sue device makers for compensation when injured by certain medical devices.
In the case of Riegel v Medtronic, the court ruled that a device maker cannot be sued under state law by patients alleging injury from a device that received marketing approval from the FDA.
“The Court’s decision has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings,” according to a March 5, 2009 press release by Representatives Frank Pallone, Jr (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry Waxman (D-CA), Chairman of the Energy and Commerce Committee, issued when introducing the Medical Device Safety Act of 2009. Read the rest of this entry »