People harmed by IVC filters made by Cook Medical have been filing lawsuits against the medical device manufacturer since 2012. Back then, the number of Cook IVC filter lawsuits was dwarfed by suits against one of Cook’s largest competitors, C.R. Bard.
Things have changed since 2012. Today, more people have filed lawsuits against Cook Medical than C.R. Bard, which is particularly astounding because Bard filters have been the subject of scrutiny for over a decade.
IVC filters are medical devices that are surgically implanted in the inferior vena cava (IVC), a large vein that transports deoxygenated blood from the lower body to the heart. Their purpose is to capture blood clots that move from the lower body toward the lungs or heart. IVC filters are intended for patients who are at high risk for developing blood clots, and for whom blood-thinning medication is either inappropriate or ineffective.
Most IVC filters are designed as a temporary measure and are to be retrieved once the imminent danger of blood clot migration has passed. The U.S. Food and Drug Administration (FDA) has recommended that IVC filters be removed 29-54 days following initial implantation. But studies have shown that the vast majority of IVC filters are never successfully retrieved, which only increases the risk of serious side effects.
The problem with IVC filters is that they occasionally migrate from their primary insertion point toward the lungs or the heart. Pieces of IVC filters have also been known to break and migrate elsewhere in the body, occasionally ending up in arterial tissue or other vital internal organs. Migration and breakage are at the heart of both the Bard and Cook IVC filter lawsuits.
Bard IVC Lawsuits Allege Company Knew of Health Risks for Years
C.R. Bard received approval from the FDA in 2002 to sell its Recovery IVC filter. Shortly thereafter, the FDA began receiving adverse event reports of death and injury, including migration and breakage, among patients who received a Recovery filter.
Rather than issue a recall, Bard replaced the Recovery model in 2005 with the G2 model. According to the G2 model, however, did not resolve any of the issues associated with the Recovery model. The company continued to sell the G2 model until 2010.
The problems with Bard IVC filters were broadcast throughout the country when NBC News ran a pointed investigative report on the company. The report even got the attention of lawmakers, like Senator Charles Grassley (R-IA), who last year sent a letter to the FDA, inquiring about the agency’s oversight of Bard filters.
Such is the backdrop for the growing number of Bard IVC filter lawsuits. As of the end of last month, Bard faced 886 lawsuits. With the amount of reports detailing the problems with Bard IVC filters, one would expect Bard to be facing more IVC filter lawsuits than other manufacturers. Indeed, Bard is facing a lot of lawsuits, but it may come as something of a surprise that the number of Cook IVC filter lawsuits is significantly higher.
How Many Cook IVC Filter Lawsuits Have Been Filed?
In June of 2016, there were 400 Cook IVC filter lawsuits filed by people all across the country. As of the end of last month, that number more than doubled to 933 lawsuits, which have been consolidated in multidistrict litigation.
What brought on the onslaught of Cook IVC filter lawsuits? Much like Bard IVC filters, Cook IVC filters have been shown to have high rates of failure. According to a June 2015 study published in the Journal of Vascular Interventional Radiology, 43 percent of patients who received a Cook IVC filter experienced vena cava perforation, which makes removal of the device exceedingly risky.
A 2012 study published in the journal Cardiovascular and Interventional Radiology examined 50 patients between 2007 and 2009 who received either a Cook IVC filter or a Gunther IVC filter. After only 71 days, 27 patients who had received a Cook IVC filter experienced some form of vena cava perforation. Of all patients, 86 percent experienced vena cava perforation.
Filing an IVC Filter Lawsuit
With spotty safety records among both companies, it comes as no surprise that Bard and Cook have been named in a growing number of lawsuits claiming IVC filter migration and/or breakage. Considerable evidence shows that C.R. Bard and Cook Medical failed to warn consumers and the medical community about the dangers associated with their IVC filters.