The issue is with retrievable inferior vena cava filters. Inferior vena cava (IVC) filters are implanted in patients who are at risk for a blood clot in the lungs when anticoagulant medication is ineffective or otherwise cannot be used. This might occur, for example, when the risk of a pulmonary embolism is short-term, possibly due to a surgery or other physical trauma.
In such cases, an IVC filter is implanted to trap blood clots and prevent them from making their way to the patient’s lungs. The filter is designed with struts (similar to legs) whose function it is to trap the blood clot. Because they are designed to mitigate the short-term risk of blood clots, retrievable filters are not designed for permanent implantation. According to an FDA Safety Communication, the longer a retrievable filter is implanted, the higher the likelihood of a serious complication.
“For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided,” the FDA warns. “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.”
In other words, patients and physicians should follow up to assess whether the risk of pulmonary embolism remains and, if it does not, the retrievable filter should be removed.
Between the two MDLs currently underway regarding IVC filters (involving Bard and Cook Medical), there are more than 1,100 lawsuits consolidated for pretrial proceedings. Those lawsuits allege that it was faulty device design and/or a defective device that is to blame for patients suffering severe internal injuries.
A 2015 report from NBC News notes that 27 deaths and 300 non-fatal complications have been linked to Bard Recovery IVC filters. Critics allege Bard - maker of the Recovery - knew about the risk of complications but continued selling the device.
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Although supporters of the device suggest it shouldn’t be left in longer than six months, Dodi Froehlich - highlighted in the NBC report - developed complications only four months after her filter was implanted. Gloria Adams, also highlighted by NBC, reportedly died a week after her filter was implanted, when a blood clot apparently pushed the entire filter into her heart.
Plaintiffs say the problem is not with them or with their doctors, it’s with devices that are prone to breaking too early, sometimes with fatal consequences.
The multidistrict litigations are MDL 2461, In Re: Bard IVC Filters Products Liability Litigation, and MDL 2570, In Re: Cook Medical, Inc, IVC Filters Marketing, Sales Practices and Products Liability Litigation.