The complaint alleges that Elizabeth Jane Hill was seriously injured when her IVC filter perforated through her inferior vena cava and migrated into her duodenum. Repeated attempts to remove the filter failed, and she lived with severe gastrointestinal symptoms, including diarrhea, vomiting, abdominal pain and fatigue. When, three years later, her new doctors succeeded in removing it, they found that some of the damage was permanent -- narrowing of the inferior vena cava where it was first implanted and the area of her intestines, where it drifted. It scarred all along the way, wherever it went.
The lawsuit asserts that Cook Medical knew or had reason to know that the IVC filter, contrary to marketing claims, was difficult or impossible to remove. But it was also not designed for long-term use in patients once the immediate danger of a pulmonary embolism had passed. It was too hard to remove and too fragile to stay.
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What happens next? The longer an IVC filter remains implanted, the higher the risk of complications. The FDA recommends removing temporary filters between 29 and 54 days after implantation. However, studies have found that 43 percent of Celect filters perforate the vena cava within two months, which is well within that period.
There is a surge of litigation. In addition to the 1,900 cases already included in the MDL, other lawsuits continue to emerge in and not all are yet included in the MDL. The outcome in Hill will determine much of what happens hereafter.