As early as 2010, reports of dangerous fractures and migrations in inferior vena cava (IVC) filters were being made public. The FDA issued a safety warning regarding these devices, stating it had received nearly 1,000 adverse event reports since 2005. Our team of IVC filter lawyers details the dangers of these filters and pending litigation against the manufacturers.
IVC filters are small, cage-like medical devices implanted into the large vein that carries blood from the lower body to the heart. They are designed to capture blood clots before they reach the lungs, heart or brain. These filters are implanted in patients, either temporarily or permanently, who are not able to receive other blood-thinning treatments.
The 2010 FDA warning stated that IVC filters are intended for short-term placement, although many are not removed after the clotting risk is gone. Unfortunately, the longer IVC filters remain implanted, the more likely it is to fracture, migrate, or perforate veins and organs. Another known and serious long-term risk of IVC implantation is deep vein embolism (DVT), which can be fatal.
One study involved 80 patients implanted with an IVC filter at a hospital in Pennsylvania, finding that two filters manufactured by Bard had particularly high rates of fracture and embolization. Two of Bard's IVC filters, the Recovery and the G2, showed significantly high fracture and embolization rates.
Bard's Recovery filter was designed to be left in place permanently and was sold from 2003 to 2005. Of the 28 patients involved in the study who received the Bard Recovery, 7 patients suffered fracture or embolization. In all cases, the filter fragments made their way through the venous system and wound up in an organ. Two patients suffered chest pain with irregular heartbeat, one had to have emergency open heart surgery to remove the fragment, and one died suddenly at home.
Patients who received Bard's G2 filter encountered similar adverse events. The study's authors concluded that it was reasonable to assume that filter fractures are directly proportional to the amount of time the filter is allowed to stay inside patients.
Bard IVC Filter Litigation Centralized in Arizona
Patients implanted with and injured by Bard's IVC filters have begun filing suit against the company. There are currently more than 20 lawsuit alleging Bard's Recovery, G2, and G2 Express filters caused serious injury. On August 17, 2015, a federal judge centralized these lawsuits into a multi-district litigation (MDL) in Arizona.
All lawsuits allege that defects in the design of Bard's IVC filters make them more likely to fracture, tilt, perforate, or migrate from the venous system. Creating an MDL improves the efficiency of these lawsuits, eliminate duplicate discovery, and reduces legal costs.
Another group of IVC filter lawsuits, against those made by Cook Medical, are currently centralized in an MDL in Indiana. There are currently about 117 lawsuits pending in this MDL.
It is estimated that 500,000 or more IVC filters from Bard and Cook have been implanted, a large percentage of which caused serious injury or death.
If you or someone you love had an IVC filter implanted and suffered a serious side effect, contact our firm now for more information on these proceedings. Our medical device lawyers offer free, no-obligation consultations to potential clients nationwide. Anyone injured by an IVC filter may be able to recover compensation for their medical bills, lost wages, or any funeral costs caused by the filter.