title: Providing Context: Medical Device Litigation and Inferior Vena Cava Filters.
abstract: Over the last few years, an increasing number of lawsuits have been filed involving inferior vena cava filters. This has prompted the U.S. Judicial Panel on Multidistrict Litigation to centralize these lawsuits into two multidistrict litigations: one for Cook's filters and one for Bard's. Both sets of cases share similar questions of facts, in particular whether these filters' design and manufacturing practices made them unreasonably prone to serious complications. The resolution of these cases will add to a larger legal debate concerning how much legal protection the 1976 Medical Device Amendments should offer firms from tort liability. As a specialty that often relies on medical devices, it is not only important for interventional radiologists to have a general understanding of medical device litigation but also to reflect upon the approaches to informed consent regarding these devices.
authors.affiliation: Department of Radiology, Northwestern University, Chicago, Illinois; Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Center for Bioethics and Medical Humanities, Northwestern University, Chicago, Illinois.
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Keller
authors.affiliation: Department of Radiology, Northwestern University, Chicago, Illinois.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Vogelzang
keywords: IVC filter; informed consent; interventional radiology; medical device litigation