IVC Filter Litigation Increases Public ScrutinyJul 7, 2016
Recent litigation involving inferior vena cava (IVC) filters has increased public scrutiny over the devices, which are used to stop blood clots from reaching the heart and lungs. Two multidistrict litigations (MDLs) have been established; one in the Southern District of Indiana over Cook Medical IVC filters and another in Arizona for C.R. Bard cases. Plaintiffs allege the filters caused serious, sometimes fatal injuries when they fractured, perforated, migrated or led to embolization.
The U.S. Food and Drug Administration (FDA) approved IVC filters in 1979. In that first year, only 2,000 devices were implanted. In 2007, that number rose to 167,000. IVC filters are used in patients who are at risk for blood clots, but cannot take blood thinners. The FDA has stated that IVC filters have the potential to fracture while inside the body. If this occurs, the pieces can migrate through the bloodstream and puncture blood vessels and organs.
There are roughly 400 lawsuits in the Cook Medical MDL and 500 in the Bard MDL. The bellwether process, in which the first cases are selected for trial, was announced for the Cook Medical litigation. Trial dates are expected for September 2016. A bellwether program has also been created for Bard, but case selection is not expected until 2017.
Plaintiffs in the IVC filter litigation allege that the manufacturer failed to warn about the risk of fracture, and other potential complications. The suits allege that the devices were designed defectively.