IVC Filter Litigation Grows

Lawsuits alleging injuries from inferior vena cava (IVC) filters continue to grow, as cases are consolidated into multidistrict litigations (MDLs) in the Southern District of Indiana and the Eastern District of Pennsylvania. Plaintiffs allege that the filters, which are placed inside a major vein in order to catch blood clots, break apart inside the body and cause severe injury.

An IVC filter is placed in patients at risk for conditions such as pulmonary embolism, where a blood clot gets lodged in the lungs. Doctors might place IVC filters in patients with venous thromboembolism or deep vein thrombosis. During the implantation procedure, a catheter is inserted into a large vein, usually in the neck or groin, and moved to the inferior vena cava, which carries deoxygenated blood from the lower and middle parts of the body to the heart. The IVC filter is placed in the catheter and attaches itself to the blood vessel wall. Some IVC filters are removable while others permanent. During filter removal, a catheter is once again inserted into a large vein.

IVC filter lawsuits have been filed against device makers including C.R. Bard and Cook Medical. A number of plaintiffs allege that they suffered injuries following an unsuccessful removal. An NBC investigation scrutinized the safety of IVC filters manufactured by Bard. According to the news report, the Recovery filter was linked to 27 deaths over the course of a decade. The investigation raised questions about whether Bard acted appropriately in testing and getting the device approved.

The journal Seminars in Interventional Radiology recently published two new studies concerning IVC filters. One study looked at complications based on the type of IVC filter used. Researchers wanted to determine which patients would benefit from retrieval versus just follow-up. The study found that filters categorized as purely conical were associated with the highest risk of penetration (90-100%). The risk of IVC thrombosis was highest with cylindrical or umbrella elements (30-50%) and Conical Bard filters were associated with the highest reported risks of fracture (40%).

The other study analyzed medical device litigation involving IVC filters. The report cited a rising number of lawsuits in recent years. The authors state that both Cook’s and Bard’s MDLs share common questions of facts, specifically whether the filter design and manufacturing practices made them unreasonably prone to complications. “The resolution of these cases will add to a larger legal debate concerning how much legal protection the 1976 Medical Device Amendments should offer firms from tort liability. As a specialty that often relies on medical devices, it is not only important for interventional radiologists to have a general understanding of medical device litigation but also to reflect upon the approaches to informed consent regarding these devices.” the authors state.