Newark, NJFollowing two reports concerning inferior vena cava filters, NBC News has released a follow-up, examining why C.R. Bard continued to sell IVC filters despite reportedly knowing about problems with the filters soon after they were approved by the Food and Drug Administration. The NBC report, based on confidential records that included a study and memo, aired on December 31, 2015. Lawsuits have been filed against companies that make IVC filters, alleging patients were put at risk of serious harm when the devices were implanted.
Inferior vena cava filters are used to prevent blood clots in patients who cannot use anticoagulant medications. According to NBC, Bard had concerns about failures with its GC series filters as early as four months after the devices were cleared by the US FDA. Despite those concerns, the G2 filter and G2 Express were left on the market another five years, with around 160,000 sold.
“The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted,” Dr. William Kuo, an expert who specializes in removing IVC filters, told NBC News. Kuo also came down hard on device makers, saying they cannot be trusted to act in the best interests of the patient.
Patients are now filing lawsuits against makers of IVC filters, alleging some filters are defectively designed and pose an unreasonable risk of harm. Included in the NBC report is Chris Svedise, who had a Bard G2 series filter implanted in 2010. When he had the filter checked in 2015, he was told it had moved dangerously close to his heart. Dr. Kuo performed emergency surgery to remove the device. During that surgery, Kuo noticed that three legs had broken off the filter. Two more broke off while Svedise was undergoing removal surgery.
According to Kuo, one of those legs could have killed Svedise.
Bard has said it stands by the safety and efficacy of its devices, but patients disagree. Regulators are also speaking out about FDA oversight of device makers. Senator Charles Grassley sent a letter to the FDA, noting concerns that data from one performance test was not passed on to the FDA, and further, “that a small clinical trial that suggested problems with the device was similarly not shared with the FDA.” The letter also notes that at least one person who was hired by Bard to help get its Recovery filter approved claims she alerted the FDA to her concerns about the device.
In 2010, the FDA issued a safety alert about the filters, warning that they should be removed as soon as the patient no longer requires intervention to prevent blood clots. At that time, the FDA said it had 328 reports of device migration, 56 reports of filter fracture, and 146 reports of the filter moving to the heart or lungs.
Of the companies that face lawsuits concerning IVC filters, two are involved in multidistrict litigation (MDL). The Bard MDL (number 2641) contains 84 actions as of February 15, 2016, while the Cook Medical MDL (number 2570) contains 255 actions.
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