Eight people who were injured by the Cordis TrapEase Permanent Vena Cava Filter or the Cordis OptEase Retrievable Vena Cava Filter say although several studies linked the filters with high rates of blood clots, fracture, and other major complications, the defendants negligently downplayed these risks. One study, published in 2012 on the JAMA Network, found that the TrapEase filter had a 64 percent fracture rate when left in place more than four years.
The TrapEase Permanent Vena Cava Filter, the first IVC filter manufactured by Cordis, was intended to be implanted into a patient’s body permanently. Cordis later created the OptEase Retrievable Vena Cava Filter, initially cleared by the U.S. Food and Drug Administration (FDA) only as a permanent device, but later receive clearance for use as an optional or retrievable filter. Both filters demonstrated a propensity to fracture, tilt, perforate, and migrate, according to court documents.
What are IVC Filters For?
The IVC (inferior vena cava) filter is a spider-like medical device used to filter blood clots and prevent them from reaching a patient’s lungs and causing a pulmonary embolism, which can result in permanent lung damage or even death. Retrievable IVC filters, such as the Cordis OptEase Retrievable Vena Cava Filter, are intended to be removed once the threat of pulmonary embolism has passed.
In 2010, FDA issued an initial communication urging removal of retrievable inferior vena cava filters once they are deemed no longer necessary. The FDA updated this communication in 2014, recommending that implanting physicians and clinicians consider the risks and benefits of filter removal for each patient and consider removing the filter as soon as protection from pulmonary embolism is no longer needed.
There are currently more than 3,000 IVC filter lawsuits against Cordis Corporation, C.R. Bard, Cook Medical, B. Braun, Rex Medical, and others pending in state and federal courts around the nation.