About IVC Filters

Inferior vena cava (IVC) filters are small, cage-like devices inserted into the inferior vena cava, a large vein carrying blood to the heart. The filters were designed to trap life-threatening blood clots and prevent them from traveling to the lungs, causing a pulmonary embolism. Some of the top manufacturers of IVC filters include C.R. Bard, the maker of the Recovery, Eclipse, G2 and G2 Express filters, Cook Medical, the maker of the Celect and Gunther Tulip filters, and Boston Scientific, the maker of the Greenfield filter, all of whom face lawsuits over IVC filter injuries.

C.R. Bard in particular has come under fire for its potentially faulty IVC filters, after it was revealed that the company likely knew about the risks associated with its Recovery filter before bringing it to market and actively concealed these risks from the public. According to reports, C.R. Bard hired regulatory specialist Kay Fuller to help get the IVC filter cleared by the FDA after its approval was initially denied in 2002. After reviewing data from Recovery clinical trials, Fuller refused to sign the clearance request, yet her signature appeared on the application anyway. C.R. Bard also hired an independent consultant to conduct a study on the safety of the Recovery filter, and when the consultant found that the filter was associated with a higher rate of complications than its competitors, Bard tried to keep the results under wraps. It was only after 27 deaths and hundreds of adverse events were reported in connection with the Recovery filter that Bard replaced the device with a modified G2 filter. Unfortunately, that device was associated with similar potentially fatal problems.

C.R. Bard isn’t the only IVC filter manufacturer plagued by reports of serious complications. There were six major recalls of IVC filters from 2005 to 2015, and in 2010, the FDA reported that retrievable IVC filters had been named in more than 900 adverse event reports in less than five years, detailing incidents where the filters fractured, perforated the inferior vena cava and migrated to other parts of the body. In 2014, the FDA issued an updated safety communication recommending that healthcare providers remove retrievable IVC filters within 29 to 54 days after implantation, so long as protection from pulmonary embolism is no longer needed. The following year, NBC News published an article linking Bard IVC filters to dozens of deaths and accused the company of not only knowing about the risks of its Recovery filter for years and doing nothing to address them, but also of replacing the problem device with a modified version it knew had similar flaws.