The makers of inferior vena cava (IVC) filters face allegations that their devices were defectively designed, putting patients at risk of injury. IVC filters are implanted to trap blood clots. Patients who are at risk of pulmonary embolism but cannot use anticoagulant medications have the devices implanted in their inferior vena cava, the blood vessel that returns blood from the patient’s lower extremities to the heart. Retrievable IVC filters are meant to be temporary interventions - used only until the risk of pulmonary embolism is gone - but some retrievable IVC filters are left implanted indefinitely, putting patients at an increased risk of device failure.
That risk caused the FDA to issue a safety alert in 2010, warning that the retrievable filters should be removed as soon as the patient no longer requires intervention to prevent blood clots.
According to CTV News (2/23/16), one of the Canadian class-action lawsuits was filed by Wendy Kopeck, who had an IVC filter implanted in August 2013. When doctors attempted to remove the filter, they discovered the filter was broken and one leg of the filter - used to trap blood clots - was piercing her internal jugular. The rest of the filter had moved to Kopeck’s small intestines. As a result, the device cannot be removed, and she must be on blood thinners for the remainder of her life.
Kopeck filed a $200 million lawsuit seeking class-action status alleging she was not warned about the risks associated with using Cook Medical’s inferior vena cava filter.
Meanwhile, Arie Kuiper also filed a lawsuit concerning a Cook Medical IVC filter. Kuiper says he has undergone two attempts to remove the filter, neither of which was successful. He was scheduled to undergo a third attempt in February.
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Although the filters perform an important, life-saving function, critics say it is possible they are being used too frequently, in patients who may not need them. Furthermore, it is possible the retrievable filters are left implanted for too long, increasing the chances of a complication. Some critics say device makers have failed to protect the interests of their patients.
In a December report by NBC, Dr. William Kuo, an expert in IVC filter removal argued that the IVC filters were never safe to be implanted.
More lawsuits are also being filed in the United States. As of March 15, 2016, there were 289 lawsuits consolidated for pretrial proceedings against Cook Medical in MDL 2570. There were also 93 lawsuits consolidated against Bard in MDL 2641.