The two multidistrict litigations involve Cook Medical (MDL 2570) and C.R. Bard (MDL 2641), and both are still in the early stages. The Cook MDL currently houses just over 650 lawsuits (as of July 15, 2016), while the Bard MDL includes slightly more than 700. As bellwether trials approach, however, the number of lawsuits added to the MDLs could continue to grow.
That's because patients who had retrievable IVC filters implanted may not have had them taken out yet, even though the retrievable filters were only meant to be implanted for a short time - until the risk of pulmonary embolism has passed. The FDA warns that filters left in too long increase the risks of a serious complication. But the question of who is responsible for problems with the filters remains. Device makers say the filters are left in too long, and it is up to patients and their doctors to follow up for device removal.
Patients and doctors say the issue is with faulty device design. Critics argue the filters should not break and definitely should not put people's lives in jeopardy even if they are left in too long. Further, they argue, some filters don't even last long enough to outlive the risk of pulmonary.
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One of the people concerned about the IVC filters was Kay Fuller, who was hired by Bard to help get its Recovery filter approved by the FDA after the agency rejected the filter. But Fuller tells NBC when she voiced her concerns about the filters - including that she did not receive important safety data - she was told she would be fired if she pursued the matter. Fuller ultimately resigned from Bard, although she alleges an application for the filter was sent to the FDA with her signature forged.
So far, at least two-dozen deaths have reportedly been linked to the Recovery filter, with another 300 non-fatal incidents.