Bills working their way through Congress would give patients the right to sue manufacturers for injuries incurred from medical devices approved by the Food and Drug Administration (FDA).
The intent of the bills, the Medical Device Safety Act of 2009 (HR 1346 and S 540 [http://thomas.loc.gov]), is to overturn a 2008 Supreme Court ruling (Riegel vs Medtronic). The ruling held that FDA approval of a device prevents a person injured by that device from suing the manufacturer in a state court.
The merits of the House bill were discussed during a May 12 hearing of the House Committee on Energy and Commerce's Health Subcommittee. At the hearing, Rep Frank Pallone Jr (D, NJ), subcommittee chairman and sponsor of the bill, said in a prepared statement that the Supreme Court decision ignored that existing laws were intended by Congress to protect patients who are injured . . . [Full Text of this Article]
