Update: Tennessee Man Files Lawsuit Over Cook Vena Cava Filter Complications
June 20, 2017 – A lawsuit (PDF) has been filed against Cook Medical by a man from Tennessee who claims he was injured after being implanted with a Günther Tulip IVC filter in November 2006. Plaintiff Robert Douglas Debord is accusing the manufacturer of negligence for selling a defective medical device, failure to warn about potential complications, and breaching both implied and express warranties. The complaint has been entered in the Cook IVC Filter multidistrict litigation (MDL No. 2570) under case number 1:16-cv-01518-SEB-MJD.
How Do IVC Filters Work?
IVC filters are placed in a patient’s inferior vena cava, a large vein that carries oxygen-depleted (blue) blood from the lower body to the heart. The devices are deigned to capture an embolism, or blood clot that has broken loose from one of the deep veins in the legs on its way to the heart and lungs.
Types of Cook IVC Filters
Cook Medical manufactures the following types of IVC filters:
- Cook Günther Tulip – Approved in 1992, this device features 4 legs and 12 filter wires that capture blood clots while still allowing blood to flow through the vena cava.
- Cook Celect – Fast-tracked to the U.S. market in 2008 via the FDA’s controversial 510(k) approval loophole, the Cook Celect IVC filter has been linked to reports of the device becoming embedded in the vena cava, which can make it difficult to remove.
What’s the Problem?
Cook IVC filters are retrievable, meaning that they are designed for short-term use and should be removed once the blood clot risk has subsided. Unfortunately, in many cases the devices are left implanted permanently, increasing the risk of adverse health complications.
In 2010, the U.S. Food & Drug Administration (FDA) issued a warning regarding problems linked to retrievable IVC filters like the Cook Celect and Günther Tulip. At the time of the warning, FDA had received at least 921 reports of filter complications including:
- Device migration
- Filter perforation
- Filter fracture
- Detached device components (“device embolization”)
Most of these events, 328 – or 35.6% – involved migration of the IVC filter. This occurs when the devices move away from where they were placed. FDA cited embolization as the 2nd most frequently reported complication.
Cook Celect Linked to 43% Strut Perforation Rate: Study
The Cook Celect IVC filter has been linked to a 43% increased strut perforation rate compared to the Option IVC filter made by Rex Medical, according to a June 2015 study titled A Comparison of Retrievability: Cook Celect versus Option Filter.
“Retrieval rates for the Celect and Option filters were not significantly different,” the researchers said. “However, retrieval of the Option filter required a significantly increased amount of fluoroscopy time compared with the Celect filter, and there was a significantly greater usage of adjunctive retrieval techniques for the Option filter. The Celect filter had a significantly higher rate of strut perforation.”
Do I Have a Cook IVC Filter Class Action Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Cook IVC Filter Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.