Trials dates have been set by the judge presiding over the Cook inferior vena cava (IVC) multidistrict litigation (MDL) in Indiana to begin 2017. Hundreds of additional lawsuits have been filed by people alleging that Cook Medical’s devices tend to break in the vein causing serious injury.
IVC filters are meant to prevent blood clots from migrating to the heart or lungs. The filter is a small, cage-like device that anchors inside the inferior vena cava, the largest vein in the body, to prevent dangerous pulmonary embolisms or strokes.
Over a quarter of a million IVC filters have been implanted in patients by 2012. It is recommended by the U.S. Food and Drug Administration (FDA) that the filters are removed one to two months after the implantation and the risk of embolism or stroke has passed.
Unfortunately, studies show these devices can be difficult to remove and breakage of the filter while inside the body is common. Hundreds of patient filed lawsuits against Cook and a panel of judges centralized the cases before U.S. District Judge Richard L. Young in the Southern District of Indiana, reports drugwatch.
Three bellwether cases allege numerous injuries caused by the Cook Celect and Gunther Tulip filters. In the case of a Florida woman, doctors were unable to remove the implanted filter. After 3 years, she experienced “persistent severe gastrointestinal symptoms, fatigue, diarrhea, vomiting, and abdominal pain.” Doctors found the filter had punctured the vein and was imbedded in the intestine. The lawsuit alleges that Cook concealed the “known risks and failed to warn of known or scientifically knowable dangers.”
In 2015, Judge Young scheduled a series of settlement talks hoping to resolve the cases before trial. Additionally, the Cook Celect and Gunther Tulip issue, plaintiffs also name C.R Bard’s G2 and Recovery filters in lawsuits. Bard may have been aware of the risks before putting its filters on the market, according to an NBC News investigation.