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As concerns continue to emerge about the risk of complications with vena cava filters, where the small devices may fracture or break inside the body, a new study suggests that the filters may have far fewer benefits than expected in preventing blood clots from reaching the heart and lungs; which is their primary purpose.
In a study published last week in the medical journal JAMA surgery, U.S. researchers looking at registry data that suggests a decline in the use of vena cava filters in recent years. However, the reduced use of the blood clot filters was not associated with any change in the rate of pulmonary embolism events.
Vena cava (IVC) filters are small, spider-shaped devices that are marketed for use among individuals at risk of suffering a pulmonary embolism. They are placed in the inferior vena cava to “catch” blood clots that may break free elsewhere in the body. However, a large number of severe and life-threateningvena cava filter side effects have emerged in recent years, particularly with the use of retrievable devices manufactured by C.R. Bard, Cook Medical and other manufactures, which were designed to be easily removed once the risk of a blood clot has passed.
Thousands of IVC filter lawsuits have been filed in recent years by individuals who experienced problems where the device failed to moved out of position, often puncturing the vein or fracturing, sending small pieces into the blood stream.
This latest study used data from the Pennsylvania Trauma Outcome Study (PTOS), involving 461,974 patients from 2003 to 2015; data from the National Trauma Data Bank (NTDB), involving 5,755,095 patients from 2003 to 2014; as well as data on 24,449,476 patients from 2003 to 2013, from the National Inpatient Sample (NIS).
The data showed significant declines in vena cava filter use over time. However, pulmonary embolism rates remained mostly unchanged. The researchers suggest that the findings suggest the filters may have “limited utility” in affecting rates of pulmonary embolism, and indicate that medical professionals should make sure they identify patients who would be most helped by prophylactic use of such filters.
IVC Filter Concerns
In May 2014, the FDA urged doctors to remove IVC filters within about one to two months after an individual was no longer at risk of suffering a pulmonary embolism, since the risk of problems appeared to be greater the longer the filter was left in place. However, many manufacturers sold the devices for years without adequately informing physicians about the risks associated with leaving them in place.
There are currently more than 1,800 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.
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 each MDL, a small group of “bellwether” cases are being prepared for early trial dates, which are designed to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. While the outcomes of these early trials will not be binding on other plaintiffs, they may influence eventual IVC filter settlements the manufacturers may reach to avoid facing hundreds of individual trials nationwide.