Medical Device Safety Act


On August 4, the Senate Health, Education, Labor and Pensions Committee held a hearing on medical devices, specifically the Medical Device Safety Act of 2009. The American Association for Justice, with the support of Alliance for Justice and Sen. Tom Harkin’s (D-IA) office, held a press conference before the hearing, with several victims of faulty medical devices attending and four speaking. Michael Mulvihill, one of the victims that spoke at the press conference, also testified before the committee.

A 64-year-old Iowan salesman who was shocked 22 times in less than an hour by a defibrillator used to regulate his heart rate while driving on the interstate has testified before a Senate subcommittee to the loss in quality of life. Because of anxiety over the possibility of repeat incidents, Michael Mulvihill of Bettendorf, Iowa had to retire early and severely curtail his mobility. His trips to the ER out of concern for what the malfunctioning device has done to his heart have greatly increased and he currently stands to receive no compensation because the Supreme Court allowed pre-emption by FDA approval for medical devices.

This is a unique double standard in the Court’s rulings, whereby people harmed by pharmaceutical products may sue for damages, but people harmed by medical devices cannot. To compensate, Congress is considering the  Medical Device Safety Act to explicitly allow consumers to seek compensation when a company’s product causes serious injury.

Michael E. Seelie, PA has represented people in Jacksonville, Florida and the surrounding communities of Orange Park, St. Augustine, Green Cove Springs, Callahan, Palatka, Fernandina Beach, Gainesville, and Lake City in pharmacuetical and medical device cases since 1978.