On March 31st, 2009, Medical Device Patients from around the country traveled to Washington, DC to appear before Congress and ask legislators to pass the Medical Device Safety Act.  Over a year before, the February 2008 decision in Riegel v. Medtronic ignored Congressional intent and disregarded 30 years of experience under the 1976 Medical Device Amendments (MDA), during which FDA regulation and state tort law worked together to protect consumers from dangerous devices. The Riegel decision gave total immunity to device manufacturers who fail to adequately warn consumers about device risks. In Riegel, the device that failed was a Medtronic balloon catheter used in heart surgery. Riegel needed additional surgery but eventually died. Now, thanks to the decision, Riegel’s heirs are left holding the bag for the manufacturer’s negligence.