A new lawsuit has been filed against Cook Medical over its IVC filter device, alleging that the blood clot filter injured a West Virginia woman. IVC filters are used in patients at risk of blood clots, which could result in pulmonary embolism (PE). They are generally used when a patient is unable to tolerate blood-thinning medication.
The Daily Hornet reports that Roseanne L. was implanted with a Celect inferior vena cava (IVC) filter by Dr. Albeir Y. Mousa on Jan. 11, 2012, at Charleston Area Medical Center in Charleston, West Virginia. She was implanted with a retrievable IVC filter, meant to be temporary. That same year, Roseanne was diagnosed with ovarian cancer.
Two years prior, the U.S. Food and Drug Administration (FDA) issued a Safety Communication urging doctors and clinicians to remove the retrievable IVC filters as soon as the risk of blood clots has subsided.
“The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides,” the safety communication states. “Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.”
The communication further states, “FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from PE is no longer needed.”
On April 12, 2016, Roseanne returned to the hospital for a follow-up appointment for her previous cancer diagnosis. She underwent a CT scan that revealed her IVC filter had tilted and perforated through the vein, a complication confirmed by Dr. Mousa.
The IVC filter “has its tip below the level of the main renal arteries,” the doctor documented. “Extraluminal extension along the inferior margin of the filter is suspected.”
Because of the dangerous position of the filter, Dr. Mousa would not attempt removal.
“As a result of the tilt, embedment, perforation of the vena cava, and inability to remove the Celect filter,” the lawsuit states, “Plaintiff faces numerous health risks, including the risk of death.”