Inferior vena cava (IVC) filters are devices that are used to prevent blood clots from reaching the heart and lungs. These small, cage-like devices are placed in the inferior vena cava, the major vein that brings blood from the lower body back to the heart. IVC filters are often used in patients who are at risk for pulmonary embolism, where a blood clot becomes lodged in the lungs, but cannot take oral anticoagulants.
Lawsuits filed over IVC filters allege that the device is subject to various complications. Plaintiffs allege that the filter migrated from its original location, fractured, damaged the walls of blood vessels or nearby organs. Some lawsuits allege that complications made retrievable difficult, ultimately forcing patients to leave them in place.
Some IVC filters are retrievable, meaning they are intended to be removed once the risk of pulmonary embolism is no longer present, while others are permanent.
The U.S. Food and Drug Administration (FDA) issued safety communications regarding IVC filters in 2010 and 2014. In 2010, the agency said it received over 900 adverse event reports related to IVC filters. Among these, 300 involved the device moving from its original location, 70 mentioned perforation of the surrounding tissue and more than 50 said the filter fractured.
In 2014, the FDA issued another safety alert; the agency cited reports of lower limb deep vein thrombosis and IVC occlusion in patients with long-term IVC filters. The agency wrote “The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.” In light of this, the FDA advised that IVC filters be removed once they are no longer necessary. The alert noted “Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes.”
Lawsuits have been filed against various IVC filter manufacturers, including C.R. Bard, Cook Medical and Boston Scientific.