A Texas woman joins nearly 1,000 other patients in their fight to hold Cook Medical responsible for producing defective IVC filters. The woman had a Cook Celect IVC filter implanted in November 2009 and suffered severe complications from the device.
The plaintiff’s IVC filter was implanted in a Fort Worth hospital to help reduce her risk of pulmonary embolism (PE). This deadly condition occurs when a blood clot forms in the lower extremities and travels up into the heart and lungs. When a blood clot reaches the heart or lungs, it can cause severe and life-threatening complications.
Unfortunately, the Texas woman suffered complications caused by the device itself. In her pleadings, she alleges Cook Medical sold and marketed a defective device without adequately warning patients like herself of the risks.
The FDA approved Cook’s Celect IVC filter in 2008 through the controversial 510(k) approval process. This means the Celect filter was not subjected to clinical trials because the FDA deemed the device nearly identical to another IVC filter, the Günther Tulip, which had already been approved by the agency.
Unfortunately, the Günther Tulip has extremely high rates of failure and the Celect IVC filter causes the same problems. Both devices are prone to perforating the inferior vena cava wall, and according to a study published in 2012, the devices have a 40% perforation rate within 71 days and an 86% perforation rate within 2.5 years.
Once an IVC filter perforates the vena cava wall, the dangerous device can become impossible to remove. Many plaintiffs in the Cook IVC filter litigation must live with further complications caused by irretrievable IVC filters.
But Cook is not the only IVC filter manufacturer facing lawsuits. C.R. Bard, Cordis Corporation, B. Bruan, Rex Medical, and Boston Scientific all face IVC filter lawsuits as well. The first IVC filter cases will go to trial next year against Cook Medical and C.R. Bard.