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The findings of new research suggests that implanting an IVC filter in trauma patients who are at risk suffering a blood clots does not appear to improve their chances of survival, raising questions about the widely used devices, which have been linked to reports of severe and life-threatening problems in recent years.
In a study published late last month in the medical journal JAMA Surgery, Boston University researchers found no significant difference in mortality rates among trauma patients implanted with inferior vena cava (IVC) filters who were at risk of blood-clot related injuries, compared to those who did not receive the filters designed to prevent blood clots from reaching the lungs and causing a pulmonary embolism.
IVC filters are small, spider-shaped devices are often implanted for individuals at risk of suffering a pulmonary embolism. They are implanted in the inferior vena cava to “catch” blood clots that may break free elsewhere in the body. However, a large number of IVC filter complications have been reported in recent years, particularly with use of retrievable devices manufactured by C.R. Bard, Cook Medical and other manufactures.
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.
In this latest study, researchers looked at data involving nearly 1,800 patients admitted to a level 1 trauma center at Boston University School of Medicine between August 1, 2003, and December 31, 2012, finding that 451 received an IVC filter, compared to 1,343 who did not.
The study looked at the mortality rates for those who were given the IVC filters and those who were not in the first 24 hours, after six months, and then after one year. The findings indicate that there was no difference in survival rates, however only eight percent of the individuals who had the filters implanted had them removed at the same facility during the follow-up period.
“The researcher herein demonstrates no significant difference in survival in trauma patients with vs without placement of an IVC filter, whether in the presence or absence of venous thrombosis,” the researchers concluded. “The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place.”
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 700 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 650 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 several thousand cases will be brought on behalf of individuals nationwide.
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.