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Cook Medical IVC Filter Bellwether Case Focuses on Celect and Gunther Tulip Models

Nov 2, 2016
Cook Medical IVC Filter Case Focus on Celect/Günther Models

U.S. District Court Judge Richard Young has announced the schedule for bellwether trials in the Cook Medical inferior vena cava (IVC) filter litigation. According to court records, the first three bellwether trials will consider injuries allegedly caused by the Celect and Günther Tulip IVC filters. The multidistrict litigation (MDL) in Indiana contains over 1,000 lawsuits alleging that the IVC filter caused complications. Plaintiffs in the litigation allege Cook Medical failed to warn patients or their doctors about the risks, which include device fracturing, migration and embolization.

Cases are consolidated into an MDL when there are numerous lawsuits with similar allegations. In the Cook Medical IVC litigation, plaintiffs allege that the blood clot-catching devices are prone to break within the blood vessel, migrating to other parts of the body and causing injury. Some plaintiffs allege that these complications make it difficult for doctors to remove.

IVC filters can be permanent or retrievable, meaning they should be taken out once the risk of a life-threatening blood clot passes. IVC filters are frequently placed in patients who cannot take oral anticoagulants. They are intended to stop blood clots from reaching the lungs, which causes a life-threatening condition known as pulmonary embolism.

Bellwether cases are the first lawsuits in an MDL selected for trial. These lawsuits are chosen specifically because they represent most plaintiffs. This representation is important because the outcome of bellwether trial is often used to gauge how the remaining litigation would play out. "[t]he purpose of selecting bellwether cases for trial is to enhance the settlement prospects of the hundreds of other pending cases involving the Celect and Günther Tulip filters. ... To further this end, the court must choose cases that are the most representative of the types of cases at issue in this MDL." the court stated.

Among the bellwether plaintiffs, two say that the IVC filter remains within their body, allegedly as a result of design defects. One plaintiff alleges that the IVC filter perforated his inferior vena cava, the major vein transporting blood from the lower body to the heart and lungs. Another plaintiff alleges that two legs of the filter broke off and became lodged elsewhere. One of the bellwether plaintiffs had the IVC filter removed, but only after one unsuccessful attempt and two years of advanced retrieval techniques.

The U.S. Food and Drug Administration (FDA) has addressed the risks associated with IVC filters. In May 2014, the agency said it received reports of complications including "device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device". The agency said it was worried that retrievable IVC filters are not always being removed once the risk of pulmonary embolism is no longer present. Subsequently, the FDA advised physicians to remove IVC filters as soon as the risk passes. "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." the agency said.

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