IVC filters are tiny, metal cage-like devices that are implanted into the inferior vena cava (IVC), a large vein in the body that delivers deoxygenated blood from the lower extremities to the heart. The filters are intended to capture blood clots that form in the legs (deep vein thrombosis) and stop them from reaching the lungs and causing potentially fatal pulmonary embolism. Ideally, the clots remain trapped in the filter until they dissolve.
Shortly after IVC filters hit the market in 2003 and 2004, reports of adverse events started flooding into the FDA’s MedWatch Adverse Event Reporting System. This prompted the FDA on Aug. 9, 2010, to issue its first Safety Communication warning of serious complications associated with the devices. On May 6, 2014, the FDA reiterated the warning in a second Safety Communication.
IVC Filter Claims and Lawsuits
More than 6,000 lawsuits have been filed against C.R. Bard and Cook Medical alleging their IVC filters are defectively designed, which makes them prone to migration, fracture, tilting or perforating the inferior vena cava, causing severe injury or death. Those suing these medical device companies claim they knew their products could cause complications but failed to adequately warn doctors or patients of the dangers they posed.
In October 2014, the Judicial Panel on Multi-district Litigation consolidated all federal cases against Cook Medical into a multi-district litigation (MDL) in the Southern District of Indiana. Currently, there are about 4,000 cases pending in that MDL.
In August 2015, all federal cases against C.R. Bard and Bard Peripheral Vascular were consolidated into a MDL in the District of Arizona. More than 3,600 cases are currently pending in that MDL.