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Researchers from the U.S. and Spain say certain patients who receive an inferior vena cava (IVC) filter after suffering a pulmonary embolism may be more likely, raising further concerns about the widespread use of the controversial blood clot filters.
In a letter published earlier this month in medical journal JAMA Internal Medicine, researchers warned that IVC filters were linked to an increased risk of 30-day mortality among seniors who were hospitalized for an acute pulmonary embolism.
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.
Researchers looked at data on more than 200,000 patients hospitalized for acute pulmonary embolism from 2011 to 2014. They found that 13.4 percent of those patients received an IVC filter. However, those who received an IVC filter had a 30-day mortality rate of 11.6 percent, compared to only 9.3 percent mortality among those who did not receive a filter.
The increased mortality rate continued when researchers looked at the data a year out from the surgeries, with those receiving IVC filters having a 20.5 percent mortality rate after one year; compared to 13.4 percent in the group that did not receive an IVC filter.
“(T)hese findings in combination with the paucity of evidence from trials raise concerns about the widespread use of these IVC filters,” the researchers concluded. “There is a need for more and better studies (randomized clinical trials or prospective controlled observational studies) to test the efficacy and safety of IVC filters across various patient subgroups.”
Another study, published in July 2018 in JAMA Network Open, found a similar increased risk of death among patients with venous thromboembolism (VTE) who received IVC filters. That study found that VTE patients faced an 18% increased risk of death within 30 days.
IVC Filter Lawsuits
The findings come as medical device manufacturers face thousands of product liability lawsuits over IVC filters, each raising similar allegations that they failed to adequately warn about the risk that the devices 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.