Boston, MATwo IVC filter makers face numerous lawsuits alleging adverse events linked to the use of IVC filters. Lawsuits against both Cook Medical and Bard allege their inferior vena cava (IVC) filters caused harm to patients who were not able to use anticoagulant medications. Among the harm reportedly linked to the use of IVC filters is migration, fracture, and tilting and perforation.
According to reports on multidistrict litigation, there are 56 lawsuits sitting in MDL 2641 (In Re: Bard IVC Filters Products Liability Litigation) as of October 15, 2015. That’s up from 50 lawsuits sitting in the multidistrict litigation as of September 15, 2015. Meanwhile, there are 133 lawsuits against Cook Medical in MDL 2570 (In Re: Cook Medical, Inc., IVC Filters Marketing, Sales, Practices And Products Liability Litigation) as of October 15, up from 120 as of September 15. Consolidation of lawsuits into a multidistrict litigation is acknowledgement that they share similar questions of fact but is not a comment on the merits of the lawsuit.
Retrievable IVC filters are used to prevent blood clots from traveling to a patient’s lungs in patients who cannot use anticoagulant medications. Some filters, however, have been linked to failure of the struts, in which the struts break off the filter potentially leading to perforation of a major blood vessel. In 2010, the US Food and Drug Administration (FDA) released a Safety Communication warning that it had received more than 900 reports of adverse events linked to the filters. The same communication noted that long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion.
“The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides,” the FDA noted.
In September 2015, NBC News published a report on IVC filters, noting that 27 deaths were linked to the Recovery filter in 10 years. Among people reportedly injured by the filter was Dodi Froehlich, 45, who had a filter implanted after a car accident increased her risk of a blood clot. Four months after receiving the filter, Dodi suffered a severe headache and found out she would need open-heart surgery because a piece of the filter had perforated her heart.
According to NBC News, a confidential study found that Bard’s Recovery filter had a higher rate of failure than its competitors’ filters, but no recall was announced. Bard has said its filters were appropriately approved by the FDA and still have significant benefits for patients.
Whether patients and the courts agree with those significant benefits remains to be seen.
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