The U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated Cook IVC filter lawsuits, in October 2014, into the U.S. District Court for the Southern District of Indiana. Over 500 plaintiffs have joined the litigation, all alleging to have been injured by Cook Celect and Gunther Tulip IVC filters.
A settlement conference held in June, 2016 was unsuccessful in finding common ground to move forward with the early bellwether cases, scheduled to begin in 2017, to be tried before juries. According to the court statement, the conference was concluded “without further order. If a settlement is not reached, all pending cases will be remanded back to their original courts of filing for individual trials.
Cook IVC filters are designed to capture and hold any clots to prevent them from traveling to the lungs causing a pulmonary embolism, a blood clot in the lungs that may be life-threatening. The small, cage-like device is implanted in the inferior vena cava which is the main vein in the body.
In some cases, the devices can break, fracture, or migrate to other parts of the body. The U.S. Food and Drug Administration (FDA) received nearly 1,000 adverse events between 2005 and 2010. Over 300 cases of device migration occurred to the heart or lungs and caused fluid buildup or arrhythmia. In approximately 150 cases, a section of the filter detached and caused blockage in the artery, and in 70 cases, the filter migrated and perforated artery walls or organs.
The FDA released a safety communication recommending doctors to remove IVC filters between 29 and 54 days after implantation, once the danger of pulmonary embolism has passed.
Researchers published a study in 2015 revealing a comparison between Cook IVC Celect filters and Rex Option filters. In about 185 patients, it was found that the Celect filter had a significantly higher rate of strut perforation. The retrieval rates between the two devices were approximately the same.
In August 2015, all federally filed cases were consolidated in the District of Arizona.