Essentially, an Inferior Vena Cava (IVC) filter is a small device implanted into a patient’s circulatory system in order to prevent blood clots from reaching the lungs and turning into pulmonary embolisms.

Unfortunately, there is a very high failure rate with this process; with parts of the filter breaking off and perforating the patients’ veins, or migrating to the heart, lungs and other vital organs and causing serious injury or death. In 2010, the FDA issued a warning about the risk of IVC filter devices, indicating it had received hundreds of adverse event reports since 2005. The types of adverse events and product problems reported by the FDA 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.

In 2012 and 2013, reliable published studies demonstrated the high rate of failure and injury from the devices was coupled with a lack of effectiveness. In May 2014, the FDA strengthened its warning and recommended that doctors remove IVC filters as soon as the risk of pulmonary embolism has passed.

Similar to TVM, there are various IVC filter manufacturers—ALN, Braun, Boston Scientific, Cordis, Crux, Rafael, etc. The two largest manufacturers appear to be Cook and Bard. The Cook lawsuits were consolidated in a Multidistrict Litigation (“MDL”) in mid-2014, and are currently pending before Judge Richard Young in the Southern District of Illinois. Just this August, the Bard lawsuits were consolidated in an MDL, and are currently pending before Judge David G. Campbell in the District of Arizona.