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As thousands of IVC filter lawsuits move forward in courts nationwide, alleging that the blood clot filters are prone to fracture or fail, the findings of a new study suggest that the devices may increase the risk of death among individuals with venous thromboembolic (VTE) disease.
In a study published last week in the medical journal JAMA Network Open, researchers with the Washington University School of Medicine found an increase in 30-day mortality among patients implanted with IVC filters with VTE who have a contraindication to blood thinners.
IVC filters are small, spider like devices that have been approved for use among individuals at risk of suffering a pulmonary embolism. While they are designed to catch blood clots that break free elsewhere in the body, and prevent them from reaching the lungs, thousands of individuals have experienced IVC filter complications, typically involving devices that were designed to be retrievable after the blood clot risk had passed.
In this latest study, researchers used two different statistical methods to sample hospitalized patients with VTE and a contraindication to coagulation. The study looked at data on more than 126,030 patients, with 45,771 treated with an IVC filter.
According to the findings, those who received an IVC filter faced an 18% increased risk of death within 30 days. That number remained constant in both statistical methods the researchers used.
“IVC filter placement was associated with increased 30-day mortality in patients with VTE and a contraindication to anticoagulation,” the researchers concluded. “Randomized clinical trials are needed to determine the efficacy of IVC filter placement in patients with VTE and a contraindication to anticoagulation.”
IVC Filter Lawsuits
The findings come as medical device manufacturers face thousands of product liability claims, each raising similar allegations that they failed to adequately warn about the risk that IVC filters may fracture, move out of position or puncture the vena cava, resulting in serious and potentially life-threatening injuries.
There are currently more than 3,500 Bard IVC filter lawsuits pending throughout the federal court system, which are currently centralized before one judge for coordinated pretrial proceedings as part of an MDL, or multidistrict litigation.
Another 1,900 Cook IVC filter lawsuits are centralized as part of a separate MDL, raising similar allegations of problems associated with filters manufactured by Cook Medical.
In April, a federal jury in Arizona ordered C.R. Bard to pay a woman $3.6 million for injuries suffered after a Bard G2 Vena Cava filter fractured inside of her body, and another bellwether trial is set to begin on May 15, involving similar problems with a Bard Eclipse IVC filter.
As IVC filter injury lawyers continue to review and file additional claims over the coming months and years, it is ultimately expected that the size of the litigation will continue to grow in the coming months and years.
While the outcomes of these early “bellwether” trials are not binding on other plaintiffs, they are designed to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. If the manufacturers fail to negotiate IVC filter settlements to resolve large numbers of cases in the coming months, they may start facing hundreds of individual trial dates nationwide.