IVC Filter Problems Increasing, Possibly Due to Aging and Fracturing Risk: Study

Reports of adverse events linked to IVC filter have increased annually by more than 25%, according to new researcher, which suggests that the risk of IVC filter problems may be increasing as devices remain in patients

Researchers warn in a new study about an increasing number of adverse events and problems with IVC filters, indicating that the small devices implanted to prevent blood clots from traveling to the lungs and causing a pulmonary embolism may be degrading and fracturing as they remain in patient’s bodies over time.

Inferior vena cava (IVC) filters have been widely used over the past few decades among individuals at risk of experiencing a pulmonary embolism, who are unable to take anticoagulants or after those medications have failed.

The filters are small spider-like devices inserted into the vein to “catch” blood clots that may break free in the body. However, a number of designs have been plagued with problems, where the struts have punctured the vena vaca, migrated out of position, or even fractured, sending small pieces into the lungs and heart, where they can cause life-threatening injuries.

Thousands of Bard IVC filter lawsuits and Cook IVC filter lawsuits have been filed in recent years, and the manufacturers of certain retrievable designs have agreed to pay millions in settlements to resolve claims involving alleged design defects.

This week, researchers with the University of California San Francisco published a letter in the medical journal JAMA Internal Medicine, indicating that they have found an increasing number of adverse events (AEs) linked in IVC filters in recent years, and the problems appear to be related to aging IVC filters that are left in place.

As part of their new study, researchers looked at IVC filter problems reported to the U.S. Food and Drug Administration (FDA) between January 1, 2016, and December 31, 2020. They also used Medicare fee-for-service claims data from 2016 to 2020, in order to estimate the number of IVC insertions annually.

According to the findings, there were 9,311 adverse events linked to IVC filters from 2016 to 2020. However, during that time, the number of reports went from 1,020 reports in 2016, to 2,842 adverse events in 2020; representing an increase of more than 25% every year.

The researchers determined that 64% of the reports were due to patient injuries, nearly 32% were due to device malfunctions, and four percent, or 377 reports, involved patient deaths.

“The increased number of AE reports may reflect the increase in device fracture risk over time, if indwelling filters are not retrieved. It is unknown the extent to which the increased number of reports reflects improved reporting or an actual increase in the number of AEs,” the researchers concluded. “Given the limited evidence of clinical benefit and the potential explanations for the trend data notwithstanding, the increasing number of US AE reports for IVCF warrants further study.”

2023 Bard IVC Filter Lawsuit Update

At the litigation’s peak, C.R. Bard faced more than 8,000 product liability lawsuits over retrievable IVC filters fracturing or breaking, each involving similar allegations that plaintiffs suffered painful and potentially complications when the small devices moved out of position, punctured internal organs or fractured, causing small pieces to travel throughout the body.

Given common questions of fact and law involved in the litigation, claims filed throughout the federal court system had been centralized in the District of Arizona since 2015, where U.S. District Judge David G. Campbell presided over coordinated discovery and pretrial proceedings as part of an MDL, or multidistrict litigation.

Following a series of early “bellwether” trials before Judge Campbell, which were designed to help parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the claims, including one trial which resulted in a $3.6 million verdict and two other claims that resulted in defense verdicts, individual IVC filter settlements were reached to resolve the vast majority of the claims.